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
276-300 of 386
Cleared Apr 16, 1998
HARPOON SUTURE ANCHORS
K973775 · MBI
Orthopedic · 195d
Cleared Apr 14, 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370 · KTT
Orthopedic · 74d
Cleared Mar 04, 1998
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
K974558 · JDI
Orthopedic · 89d
Cleared Jan 30, 1998
CRANIOFACIAL ANCHORS
K974136 · MBI
Orthopedic · 88d
Cleared Jan 30, 1998
LACTOSORB PANELS
K974309 · HRS
Orthopedic · 74d
Cleared Dec 04, 1997
REACH FEMORAL HIP COMPONENT
K971824 · LPH
Orthopedic · 202d
Cleared Oct 15, 1997
ABC TOTAL ELBOW PROTHESIS
K972691 · JDB
Orthopedic · 90d
Cleared Aug 25, 1997
REPICCI II UNICONDYLAR KNEE
K971938 · HRY
Orthopedic · 90d
Cleared Aug 19, 1997
LACTOSORB TRAUMA PLATING SYSTEM
K971870 · HRS
Orthopedic · 90d
Cleared Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431 · LZO
Orthopedic · 279d
Cleared Aug 07, 1997
RECOVERY PROTRUSIO CAGE
K971890 · JDI
Orthopedic · 77d
Cleared Jul 18, 1997
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · HSB
Orthopedic · 63d
Cleared Apr 30, 1997
PEGGED ACETABULAR COMPONENT
K970501 · LPH
Orthopedic · 79d
Cleared Apr 03, 1997
BIOMET BONE SCREW
K964970 · HWC
Orthopedic · 112d
Cleared Apr 02, 1997
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · HSD
Orthopedic · 365d
Cleared Mar 17, 1997
KIRSCHNER KNEE MODIFIED
K961021 · JWH
Orthopedic · 368d
Cleared Feb 18, 1997
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR...
K960363 · MJT
Orthopedic · 390d
Cleared Dec 16, 1996
ADVANTAGE MAPF HIP FEMORAL COMPONENT
K960643 · KWY
Orthopedic · 306d
Cleared Dec 04, 1996
CEMENT-ON FEMORAL STEM
K963709 · JWH
Orthopedic · 79d
Cleared Nov 27, 1996
KONSTRUCT PATELLAR COMPONENT
K960856 · JWH
Orthopedic · 271d
Cleared Sep 17, 1996
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR...
K960984 · JDI
Orthopedic · 190d
Cleared Aug 05, 1996
COCR BI-ANGULAR HUMERAL COMPONENT
K961571 · KWT
Orthopedic · 104d
Cleared Jun 21, 1996
FENNING FEMORAL COMPONENT
K960303 · LPH
Orthopedic · 151d
Cleared Mar 13, 1996
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
K943025 · JWH
Orthopedic · 625d
Cleared Feb 16, 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · LZO
Orthopedic · 87d

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