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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS TYPES AND SIZES OF INTRAMEDULLARY NAILS AND ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: GAUGE, DEPTH Generic Device Name: VARIOUS TYPES AND SIZES OF DEPTH GAUGES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: TEMPLATE Generic Device Name: VARIOUS TYPES AND SIZES OF TEMPLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: WRENCH Generic Device Name: VARIOUS TYPES AND SIZES OF WRENCHES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: TAMP Generic Device Name: VARIOUS TYPES AND SIZES OF BONE TAMPS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS TYPES AND SIZES OF WIRE PASSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: BENDER Generic Device Name: VARIOUS TYPES AND SIZES OF BENDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES AND SIZES OF WIRE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: VARIOUS TYPES AND SIZES OF INVASIVE TRACTION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PROSTHESIS, RIB REPLACEMENT Generic Device Name: VERTICAL EXPANDABLE PROSTHETIC RIB, VEPTR Proprietary Device Name: VERTICAL EXPANDABLE PROSTHETIC RIB, VEPTR Registered Establishment Name: SYNTHES (USA). |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS TYPES OF SCISSORS INCLUDING;LISTER AND BRUN'S Proprietary Device Name: PLASTER AND BANDAGE Registered Establishment Name: FAIRMOUNT INDUSTRIES PVT. LTD. |
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Classification: RONGEUR Generic Device Name: VARIOUS TYPES OF BONE RONGEURS INCLUDING; STILE, LUER'S ETC. Proprietary Device Name: BONE RONGEURS Registered Establishment Name: FAIRMOUNT INDUSTRIES PVT. LTD. |
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Classification: SPLINT, TRACTION Generic Device Name: KNEE SPLINT Proprietary Device Name: KNEE SPLINT Registered Establishment Name: NEPTUNE ORIENT CO.,LTD.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: VARIOUS KNIVES AND REPLACEMENT BLADES Proprietary Device Name: MULTIPLE Registered Establishment Name: SCANDMED AB. |
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Classification: PROBE Generic Device Name: VARIOUS PROBES Proprietary Device Name: MULTIPLE Registered Establishment Name: SCANDMED AB. |
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Classification: COMPONENT, CAST Generic Device Name: UNDERCAST PADDING Proprietary Device Name: UNDERCAST PADDING Registered Establishment Name: UNIVERSAL WEAVERS CORP.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, CEMENTED Generic Device Name: CERAMIC HIP BALL Proprietary Device Name: SCT ALUMINA FEMORAL HEAD Registered Establishment Name: SOCIETE DES CERAMIQUES TECHNIQUES. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES OF DRILL BITS Proprietary Device Name: DRILL BIT Registered Establishment Name: INTERPHASE IMPLANTS, INC.. |
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Classification: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Generic Device Name: HIP JOINT METAL/POLYMER CONSTRAINED CEMENTED OR UNCEMENTED PROSTHESIS Proprietary Device Name: INTRINSIC HIP STEM Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: ACETABULAR COMPONENT Proprietary Device Name: VARIOUS TYPES OF ACETABULAR COMPONENTS Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL INSTRUMENT Proprietary Device Name: VARIOUS TYPES OF ORTHOPEDIC MANUAL INSTRUMENTS Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: REAMER Generic Device Name: REAMER Proprietary Device Name: VARIOUS TYPES OF REAMERS Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: HIP PROSTHESIS Proprietary Device Name: VARIOUS TYPES OF HIP PROSTHESIS Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: HOOK, ROD, AND THOROCOLUMBAR SCREW SPINAL FIXATION SYSTEM Proprietary Device Name: CONTOUR SPINAL SYSTEM Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE Generic Device Name: HA COATED, CEMENTLESS HIP PROSTHESIS Proprietary Device Name: TRIFIX J HIP PROSTHESIS Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: PEDICALE SCREW FIXATION SYSTEM Proprietary Device Name: CONTOUR SPINAL SYSTEM Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: KNEE PROSTHEISIS Proprietary Device Name: ORTHO DEVELOPMENT BALANCED KNEE SYSTEM Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: INTERVERTEBRAL BODY FUSION DEVICE Proprietary Device Name: IBS INTERBODY SPACER SYSTEM Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: SPINAL SPACER Proprietary Device Name: IBS SPACER Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL Generic Device Name: SPINAL FIXATION PLATE Proprietary Device Name: OCU PLATE SYSTEM Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: HIP PROSTHESIS Proprietary Device Name: TRI-FIX J FEMORAL STEM AND ACETABULAR CUP Registered Establishment Name: ORTHO DEVELOPMENT CORP.. |
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Classification: BIT, DRILL Generic Device Name: TWIST DRILL Proprietary Device Name: TWIST DRILL Registered Establishment Name: OSM GMBH. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS SIZES OF DRILL BITS Proprietary Device Name: TWIST DRILL Registered Establishment Name: BARAMED CHIRURGIE DENTAL VETERINAR. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: SPRING DRUM TRACTION SYSTEM Proprietary Device Name: SPRING DRUM TRACTION SYSTEM Registered Establishment Name: ECONOMIC HOLLAND B.V.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: CELITA SCISSORS Proprietary Device Name: CELITA SCISSORS Registered Establishment Name: CELITA INSTRUMENT CO.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: NEEDLEHOLDER Proprietary Device Name: CELITA NEEDHOLDER Registered Establishment Name: CELITA INSTRUMENT CO.. |
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Classification: GAUGE, DEPTH Generic Device Name: VARIOUS TYPES OF GAUGES Proprietary Device Name: MULTIPLE Registered Establishment Name: KLS-MARTIN L.P.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: KLS-MARTIN L.P.. |
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Classification: AWL Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: KLS-MARTIN L.P.. |
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