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
351-375 of 441
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 May 02, 1994
POLY-MEDICS HEAT PACK
K941245 · IMD
Physical Medicine · 48d
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
Cleared Feb 16, 1994
RANAWAT/BURSTEIN TOTAL HIP SYSTEM
K921277 · LPH
Orthopedic · 701d
Cleared Feb 16, 1994
TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
K921301 · LPH
Orthopedic · 700d
Cleared Feb 16, 1994
PMI HIP FEMORAL
K923452 · LPH
Orthopedic · 582d
Cleared Feb 15, 1994
METALLIC TOATAL HIP SYSTEM
K921274 · LPH
Orthopedic · 700d
Cleared Jul 28, 1993
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
K926107 · LPH
Orthopedic · 237d
Cleared Jul 23, 1993
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
K921182 · JWH
Orthopedic · 500d
Cleared May 05, 1993
HARPOON SUTURE ANCHOR
K926037 · JDR
Orthopedic · 155d
Cleared Mar 22, 1993
TOTAL TOE SYSTEM
K920446 · LZJ
Orthopedic · 412d
Cleared Nov 04, 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641 · LZO
Orthopedic · 323d
Cleared Aug 13, 1992
AGC AND MAXIM KNEE COMPONENTS WITH NTS
K922285 · JWH
Orthopedic · 90d
Cleared Jul 01, 1992
HEALEY REVISION COMPONENT SYSTEM
K921139 · JDL
Orthopedic · 113d
Cleared Jun 30, 1992
RX 90 ACETABULAR COMPONENT SYSTEM
K920639 · JDI
Orthopedic · 139d
Cleared Jun 30, 1992
FULL HEMISPHERE RING-LOC LINER
K920640 · JDI
Orthopedic · 139d
Cleared Jun 30, 1992
INTEGRATED ENDOSCOPY SYSTEM 1000
K920800 · HRX
Orthopedic · 130d
Cleared Apr 13, 1992
BIOMET NTS FEMORAL COMPONENTS
K920161 · JDI
Orthopedic · 90d

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