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
101-125 of 386
Cleared Jul 19, 2005
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
K050210 · JWH
Orthopedic · 172d
Cleared Jun 29, 2005
TAPER 2 POROUS FEMORAL STEM
K050441 · JDI
Orthopedic · 127d
Cleared Jun 29, 2005
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
K051411 · LZO
Orthopedic · 29d
Cleared May 27, 2005
BALANCE HIP SYSTEM
K050251 · KWA
Orthopedic · 113d
Cleared Apr 28, 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989 · LPH
Orthopedic · 181d
Cleared Mar 25, 2005
BIOLOX DELTA CERAMIC HEADS
K042091 · LZO
Orthopedic · 234d
Cleared Mar 08, 2005
ARCOMXL POLYETHYLENE LINERS
K042051 · LPH
Orthopedic · 221d
Cleared Feb 17, 2005
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
K043100 · MBF
Orthopedic · 100d
Cleared Feb 11, 2005
VANGUARD SSK KNEE SYSTEM
K042757 · JWH
Orthopedic · 130d
Cleared Feb 09, 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · KWT
Orthopedic · 51d
Cleared Jan 21, 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
K042774 · LPH
Orthopedic · 108d
Cleared Jan 14, 2005
TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
K043537 · LPH
Orthopedic · 23d
Cleared Dec 21, 2004
M2A/C2A ACETABULAR SYSTEM
K042841 · JDL
Orthopedic · 68d
Cleared Dec 14, 2004
BIO-CORE INTERFERENCE SCREW
K042552 · HWC
Orthopedic · 85d
Cleared Dec 02, 2004
MODULAR ARTHRODESIS NAIL
K042409 · HSB
Orthopedic · 90d
Cleared Nov 09, 2004
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
K042029 · LPH
Orthopedic · 104d
Cleared Nov 01, 2004
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · HRY
Orthopedic · 90d
Cleared Oct 20, 2004
ARTHROTEK MENISCAL HYBRID DEVICE
K041988 · JDR
Orthopedic · 89d
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 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

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