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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: VARIOUS TYPES OF HIP PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES OF EXTERNAL WRIST PLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: VARIOUS TYPES OF FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEE PROSTHESIS Proprietary Device Name: PATIENT MATCHED TITANIUM ALLOY TROCHLEA REPLACEMENT Registered Establishment Name: BIOMET, INC.. |
Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: VARIOUS TYPES OF BONE GRAFT SUBSTITUTE Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: VARIOUS TYPES OF HIP PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: EVACUATOR, VAPOR, CEMENT MONOMER Generic Device Name: CEMENTATION SYSTEM Proprietary Device Name: OPTIVAC CEMENTATION SYSTEM Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: VARIOUS TYPES OF SHOULDER PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS TYPES OF ULTRASONIC BONE CUTTING INSTRUMENTS Proprietary Device Name: ULTRA-DRIVE 3 Registered Establishment Name: BIOMET, INC.. |
Classification: BONE CEMENT, ANTIBIOTIC Generic Device Name: VARIOUS TYPES OF BONE CEMENT Proprietary Device Name: PALACOS G BONE CEMENT WITH GENTAMICIN Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UHMWPE, PEGGED, UNCEMENTED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEE PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING Generic Device Name: VARIOUS TYPES OF KNEE PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: VARIOUS TYPES OF ELBOW PROSTHESIS Proprietary Device Name: MODULAR RADIAL HEAD Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEE COMPONENTS Proprietary Device Name: ASCENT POROUS OPEN BOX PS FEMORAL COMPONENTS Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH Generic Device Name: VARIOUS TYPES OF STERILE HIP COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL Generic Device Name: VARIOUS TYPES OF STERILE HIP COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) Generic Device Name: VARIOUS TYPES OF STERILE HIP COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Generic Device Name: VARIOUS TYPES OF STERILE HIP COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: VARIOUS SIZES OF NON-STERILE PENILE MOLDS Proprietary Device Name: PENLE MOLD Registered Establishment Name: COOK UROLOGICAL, INC.. |
Classification: EXTRACTOR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: COOK UROLOGICAL, INC.. |
Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: HIP INSTRUMENTS, KNEE INSTRUMENTS, ORTHOPEDIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYMMETRY MEDICAL USA, INC.. |
Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYMMETRY MEDICAL USA, INC.. |
Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYMMETRY MEDICAL USA, INC.. |
Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYMMETRY MEDICAL USA, INC.. |
Classification: AWL Generic Device Name: RC AWL Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: SYMMETRY MEDICAL USA, INC.. |
Classification: TAMP Generic Device Name: BONE TAMP Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: SYMMETRY MEDICAL USA, INC.. |
Classification: TREPHINE Generic Device Name: TREPHINE Proprietary Device Name: ORTHOPEDIC MANUAL / SURGICAL INSTRUMENT Registered Establishment Name: SYMMETRY MEDICAL USA, INC.. |
Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: ARTHROSCOPIC INSTRUMENT Proprietary Device Name: ARTHO Registered Establishment Name: MECTRA LABS, INC.. |
Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: SURGICAL INSTRUMENTS Proprietary Device Name: INNOMED, INC. INSTRUMENTS FOR ORTHOPAEDIC SURGERY Registered Establishment Name: INNOMED CORP.. |
Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: HIP DISTRACTOR Proprietary Device Name: INNOMED, INC. HIP DISTRACTOR Registered Establishment Name: INNOMED CORP.. |
Classification: EXTRACTOR Generic Device Name: EXTRACTORS Proprietary Device Name: INNOMED, INC. EXTRACTION INSTRUMENTS Registered Establishment Name: INNOMED CORP.. |
Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: CAST CUTTING GUIDE AND CAST STAND Proprietary Device Name: INNOMED, INC. CAST CUTTING GUIDE AND CAST STAND Registered Establishment Name: INNOMED CORP.. |
Classification: POSITIONER, SOCKET Generic Device Name: DAILY ACTIVITY ASSIST DEVICE Proprietary Device Name: SOCK STARTER Registered Establishment Name: THE VERNON CO.. |
Classification: BELT, PELVIC, TRACTION Generic Device Name: MENS OR LADIES PELVIC TRACTION BELT Proprietary Device Name: SAME Registered Establishment Name: ACCELERATED CARE PLUS CORP.. |
Classification: HALTER, HEAD, TRACTION Generic Device Name: TRACTION HEAD HALTER FOR MEN OR LADIES Proprietary Device Name: SAME Registered Establishment Name: ACCELERATED CARE PLUS CORP.. |
Classification: BELT, PELVIC, TRACTION Generic Device Name: MENS OR LADIES PELVIC TRACTION BELT Proprietary Device Name: SAME Registered Establishment Name: ACCELERATED CARE PLUS CORP.. |
Classification: BIT, DRILL Generic Device Name: BONE DRILL Proprietary Device Name: BONE DRILL Registered Establishment Name: INTEGRA LIFESCIENCES CORP.. |
Classification: BELT, PELVIC, TRACTION Generic Device Name: VARIOUS TYPES OF PELVIC TRACTION BELTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SCOTT SPECIALTIES, INC.. |
Classification: HALTER, HEAD, TRACTION Generic Device Name: VARIOUS TYPES OF HEAD HALTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SCOTT SPECIALTIES, INC.. |
Classification: INSTRUMENT, CAST REMOVAL, AC-POWERED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: M-PACT WORLDWIDE, LLC.. |
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