Medical Device Manufacturer · US , Warsaw , IN

Biomet Manufacturing, Inc.

32 submissions · 32 cleared · Since 1999
32
Total
32
Cleared
0
Denied

Biomet Manufacturing, Inc. — FDA 510(k) Submissions

Biomet Manufacturing, Inc. has submitted 32 FDA 510(k) premarket notifications since 1999, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Screw, Fixation, Bone, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
COMPREHENSIVE CONVERTIBLE GLENOID
K130390 · PHX Shoulder Prosthesis,... · Orthopedic
Oct 2013 236d
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
K113271 · KWA Prosthesis, Hip,... · Orthopedic
May 2012 196d
COMPREHENSIVE REVERSE SHOULDER
K113121 · PHX Shoulder Prosthesis,... · Orthopedic
Dec 2011 56d
HIPLOC COMPRESSION HIP SCREW
K080685 · JDO Device, Fixation,... · Orthopedic
Aug 2008 157d
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
K080088 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2008 149d
BIOMET CABLE SYSTEM
K071271 · JDQ Cerclage, Fixation · Orthopedic
Oct 2007 169d
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
K070399 · JDI Prosthesis, Hip,... · Orthopedic
May 2007 81d
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
K063515 · HRY Prosthesis, Knee,... · Orthopedic
Feb 2007 73d
23 MM SINGLE-PEG PATELLA COMPONENT
K061340 · JWH Prosthesis, Knee,... · Orthopedic
Sep 2006 133d
VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE
K061433 · MBH Prosthesis, Knee,... · Orthopedic
Aug 2006 89d
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS
K053505 · MBH Prosthesis, Knee,... · Orthopedic
Aug 2006 241d
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
K052639 · JDI Prosthesis, Hip,... · Orthopedic
May 2006 219d
XR-SERIES BI-METRIC FEMORAL COMPONENTS
K052089 · LPH Prosthesis, Hip,... · Orthopedic
Feb 2006 199d
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299 · HRY Prosthesis, Knee,... · Orthopedic
Jan 2006 41d
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
K051479 · KRO Prosthesis, Knee,... · Orthopedic
Aug 2005 68d
MAESTRO CARPAL HEMIARTHROPLASTY
K050028 · KWN Prosthesis, Wrist, Carpal... · Orthopedic
Mar 2005 78d
MEDALLION MODULAR HIP SYSTEM
K041850 · LPH Prosthesis, Hip,... · Orthopedic
Dec 2004 166d
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · MQV Filler, Bone Void,... · Orthopedic
Aug 2004 127d
VERSA-DIAL HUMERAL HEAD
K040610 · KWS Prosthesis, Shoulder,... · Orthopedic
Jun 2004 88d
VANGUARD PATELLA COMPONENTS
K040770 · JWH Prosthesis, Knee,... · Orthopedic
Apr 2004 28d
TITANIUM TOGGLE BUTTON(S)
K033838 · MBI Fastener, Fixation,... · Orthopedic
Feb 2004 65d
G4 SLEEVED NAIL
K020962 · HSB Rod, Fixation,... · Orthopedic
May 2002 60d
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2001 123d
METAL SCREW ANCHOR
K012503 · MBI Fastener, Fixation,... · Orthopedic
Oct 2001 80d
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · HSD Prosthesis, Shoulder,... · Orthopedic
Sep 2001 192d
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