Medical Device Manufacturer · US , Mchenry , IL

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

441 submissions · 419 cleared · Since 1978
441
Total
419
Cleared
0
Denied
441 devices
126-150 of 441
Cleared Oct 07, 2004
MAESTRO TOTAL WRIST
K042032 · JWJ
Orthopedic · 71d
Cleared Oct 01, 2004
M2A MAGNUM SYSTEM
K042037 · KWA
Orthopedic · 64d
Cleared Jul 30, 2004
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K041352 · KRO
Orthopedic · 71d
Cleared Jul 08, 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · HAW
Neurology · 428d
Cleared Jun 04, 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · KWI
Orthopedic · 88d
Cleared Jun 02, 2004
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE...
K033489 · MBH
Orthopedic · 211d
Cleared May 21, 2004
MICROMAX SUTURE ANCHOR
K040475 · HWC
Orthopedic · 87d
Cleared May 21, 2004
MAXIM ACCEL (VANGUARD) PS+ BEARINGS
K041046 · JWH
Orthopedic · 29d
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 22, 2003
ULTRA-DRIVE 3
K031280 · JDX
Neurology · 153d
Cleared Sep 15, 2003
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · HAW
Neurology · 140d
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

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