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
126-150 of 386
Cleared Apr 27, 2004
CALCIGEN -NAP BONE VOID FILLER
K033611 · MQV
Orthopedic · 162d
Cleared Apr 16, 2004
IM TOTAL FEMUR
K033871 · JDI
Orthopedic · 126d
Cleared Feb 02, 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · KWS
Orthopedic · 89d
Cleared Dec 19, 2003
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · JDC
Orthopedic · 70d
Cleared Dec 18, 2003
COMPRESS DISTAL FEMORAL REPLACEMENT
K031804 · KRO
Orthopedic · 190d
Cleared Dec 17, 2003
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · LOD
Orthopedic · 342d
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · HRS
Orthopedic · 28d
Cleared Nov 20, 2003
BI-ANGULAR SHOULDER SYSTEM
K032895 · MBF
Orthopedic · 64d
Cleared Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · HWC
Orthopedic · 30d
Cleared Sep 05, 2003
INTERLOK BIO-MODULAR HUMERAL STEMS
K032507 · KWT
Orthopedic · 22d
Cleared Aug 21, 2003
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K032396 · JDI
Orthopedic · 17d
Cleared Aug 11, 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055 · LPH
Orthopedic · 217d
Cleared Aug 06, 2003
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693 · LPH
Orthopedic · 65d
Cleared Jul 01, 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · JDI
Orthopedic · 27d
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · LPH
Orthopedic · 86d
Cleared Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · KWT
Orthopedic · 90d
Cleared May 22, 2003
TEXAS T - PLATE
K031334 · HRS
Orthopedic · 24d
Cleared Mar 20, 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501 · LPH
Orthopedic · 29d
Cleared Mar 06, 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446 · HRY
Orthopedic · 23d
Cleared Feb 26, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · MQV
Orthopedic · 40d
Cleared Jan 23, 2003
OSTEO-CABLE SLEEVE
K024022 · HXN
Orthopedic · 49d
Cleared Jan 23, 2003
FREEDOM CONSTRAINED LINERS
K030047 · KWZ
Orthopedic · 17d
Cleared Jan 17, 2003
MAXIM ACCEL KNEE SYSTEM
K023546 · JWH
Orthopedic · 87d
Cleared Dec 30, 2002
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
K024037 · JWH
Orthopedic · 24d
Cleared Dec 02, 2002
MODULAR HEAD BONE SCREW
K022952 · HWC
Orthopedic · 88d

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