Medical Device Manufacturer · US , Mchenry , IL

Biomet, Inc. - FDA 510(k) Cleared Devices

440 submissions · 418 cleared · Since 1978
440
Total
418
Cleared
0
Denied
386 devices
76-100 of 386
Cleared Jan 15, 2009
BIOLOX DELTA OPTION CERAMIC HEADS
K082996 · LZO
Orthopedic · 99d
Cleared Oct 15, 2008
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
K082446 · KWA
Orthopedic · 51d
Cleared Jul 09, 2008
COMPREHENSIVE REVERSE SHOULDER
K080642 · PHX
Orthopedic · 125d
Cleared Jun 11, 2008
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A...
K080330 · KRO
Orthopedic · 126d
Cleared Apr 21, 2008
REGENEREX TIBIAL COMPONENTS
K080361 · MBH
Orthopedic · 70d
Cleared Mar 20, 2008
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
K080204 · JWH
Orthopedic · 52d
Cleared Jul 02, 2007
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
K071569 · MBI
Orthopedic · 24d
Cleared Jun 29, 2007
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
K071053 · KXA
Orthopedic · 77d
Cleared May 03, 2007
100KGY E-POLY MAXROM ACETABULAR LINERS
K070364 · JDI
Orthopedic · 85d
Cleared Mar 09, 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369 · LPH
Orthopedic · 29d
Cleared Jun 06, 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312 · LZO
Orthopedic · 27d
Cleared Dec 16, 2005
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH...
K052990 · KWY
Orthopedic · 53d
Cleared Nov 23, 2005
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
K052255 · LPH
Orthopedic · 97d
Cleared Oct 27, 2005
ORTHOPEDIC SALVAGE SYSTEM- OSS
K052685 · KRO
Orthopedic · 29d
Cleared Oct 04, 2005
POROUS COATED ACETABULAR COMPONENTS
K050124 · KWA
Orthopedic · 258d
Cleared Sep 29, 2005
RINGLOC BI-POLAR ACETABULAR COMPONENT
K051569 · JDI
Orthopedic · 107d
Cleared Sep 29, 2005
COPELAND EAS HUMERAL RESURFACING HEADS
K051843 · HSD
Orthopedic · 84d
Cleared Sep 27, 2005
E-POLY (VITAMIN E) ACETABULAR LINERS
K050327 · LPH
Orthopedic · 230d
Cleared Sep 06, 2005
POROUS COATED DISCOVERY ELBOW
K051975 · JDC
Orthopedic · 47d
Cleared Aug 16, 2005
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
K050222 · MBH
Orthopedic · 197d
Cleared Aug 05, 2005
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
K043547 · KWA
Orthopedic · 225d
Cleared Aug 05, 2005
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385 · KWI
Orthopedic · 70d
Cleared Aug 05, 2005
AVL HINGE KNEE SYSTEM
K051570 · KRO
Orthopedic · 52d
Cleared Aug 04, 2005
COBALT BONE CEMENT
K051496 · LOD
Orthopedic · 59d
Cleared Aug 03, 2005
COBALT G HV BONE CEMENT
K051532 · LOD
Orthopedic · 55d

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