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
326-350 of 386
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
Cleared Mar 11, 1992
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · KWT
Orthopedic · 89d
Cleared Mar 10, 1992
IONGUARD TITANIUM MODULAR HEADS
K915548 · LZY
Orthopedic · 90d
Cleared Feb 11, 1992
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM
K915132 · JWH
Orthopedic · 90d
Cleared Jan 16, 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420 · LZO
Orthopedic · 175d
Cleared Jan 02, 1992
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K911802 · JDI
Orthopedic · 254d
Cleared Dec 20, 1991
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · JDI
Orthopedic · 184d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369 · MEH
Orthopedic · 135d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · MEH
Orthopedic · 135d
Cleared Aug 19, 1991
AGC REVISION KNEE PROTHESIS
K912245 · JWH
Orthopedic · 90d
Cleared Jul 26, 1991
FINN KNEE PROSTHESIS
K910877 · KRO
Orthopedic · 147d

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