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
301-325 of 386
Cleared Feb 14, 1996
FINN KNEE SYSTEM
K945028 · KRO
Orthopedic · 489d
Cleared Jan 31, 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925 · LZO
Orthopedic · 166d
Cleared Dec 11, 1995
A-B ACETABULAR COMPONENT
K954417 · LPH
Orthopedic · 81d
Cleared Oct 31, 1995
LACTOSORB BONE PIN
K953194 · HTY
Orthopedic · 113d
Cleared Sep 19, 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686 · LZO
Orthopedic · 99d
Cleared Jul 03, 1995
HARPOON SUTURE ANCHORS
K943806 · HWC
Orthopedic · 333d
Cleared May 15, 1995
RINGLOC CONSTRAINED LINER
K950202 · KWZ
Orthopedic · 117d
Cleared May 02, 1995
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · JDI
Orthopedic · 196d
Cleared May 02, 1995
INDEX ACETABULAT COMPONENT
K950761 · JDI
Orthopedic · 74d
Cleared Feb 02, 1995
BONE MULCH SCREW
K941941 · HWC
Orthopedic · 287d
Cleared Dec 19, 1994
TOTAL TOE SYSTEM II
K941650 · LZJ
Orthopedic · 258d
Cleared Oct 17, 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · LZO
Orthopedic · 87d
Cleared Oct 14, 1994
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · KWT
Orthopedic · 708d
Cleared Sep 20, 1994
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · JDG
Orthopedic · 118d
Cleared Sep 19, 1994
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
K942027 · JDG
Orthopedic · 146d
Cleared Sep 19, 1994
RX90 FEMORAL COMPONENT
K942028 · JDG
Orthopedic · 146d
Cleared Aug 01, 1994
ARTHROTEK SET SCREW
K932721 · HWC
Orthopedic · 423d
Cleared May 05, 1994
CO-CR ANSWER FEMORAL COMPONENT
K931194 · JDG
Orthopedic · 422d
Cleared Mar 24, 1994
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · HRX
Orthopedic · 275d
Cleared Mar 24, 1994
ARTHROTEK CANNULA SYSTEM
K934401 · HRX
Orthopedic · 196d
Cleared Mar 10, 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · LZO
Orthopedic · 504d
Cleared Feb 23, 1994
ARTHROTEK INTERFERENCE SCREW
K934469 · HWC
Orthopedic · 166d
Cleared Feb 16, 1994
MALLORY-HEAD TOTAL HIP SYSTEM
K921181 · LZO
Orthopedic · 708d
Cleared Feb 16, 1994
BIMETRIC TOTAL HIP SYSTEM
K921224 · LZO
Orthopedic · 705d
Cleared Feb 16, 1994
INTEGRAL TOTAL HIP SYSTEM
K921225 · LZO
Orthopedic · 705d

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