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
351-375 of 386
Cleared Jul 16, 1991
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)
K911718 · JDI
Orthopedic · 90d
Cleared Jul 15, 1991
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
K911685 · JDI
Orthopedic · 90d
Cleared Jun 27, 1991
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K911684 · JDI
Orthopedic · 72d
Cleared Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
K905687 · LZO
Orthopedic · 117d
Cleared Feb 17, 1988
VOLZ TOTAL WRIST PROSTHESIS
K880156 · KWM
Orthopedic · 35d
Cleared Jan 20, 1988
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · HRY
Orthopedic · 149d
Cleared Aug 27, 1987
BIOMET MODULAR SHOULDER PROSTHESIS
K872454 · KWT
Orthopedic · 65d
Cleared Jan 28, 1987
BROOKER BIO-GROOVE FEMORAL COMPONENT
K864085 · KWL
Orthopedic · 100d
Cleared Oct 27, 1986
UNIVERSAL ACETABULAR COMPONENT
K861433 · JDI
Orthopedic · 194d
Cleared Apr 17, 1986
MALLORY/HEAD - PF ACETABULAR COMPONENT
K861114 · JDI
Orthopedic · 23d
Cleared Nov 01, 1985
MALLORY/HEAD TOTAL HIP SYSTEM
K853259 · KMC
Orthopedic · 91d
Cleared Aug 22, 1985
POROUS APF/MODULAR FEMORAL COMPONENT
K852585 · JDI
Orthopedic · 65d
Cleared Aug 15, 1985
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · KWL
Orthopedic · 58d
Cleared Apr 19, 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · KWL
Orthopedic · 113d
Cleared Mar 05, 1985
CFE ACETABULAR CUP
K844941 · JDI
Orthopedic · 75d
Cleared Feb 21, 1985
BROOKER ACETABULAR CUP
K845005 · JDI
Orthopedic · 57d
Cleared Jun 25, 1984
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · KWL
Orthopedic · 80d
Cleared Jan 31, 1984
AGC TOTAL KNEE PROSTHESIS
K833921 · JWH
Orthopedic · 78d
Cleared Dec 22, 1983
BIOMET BIPOLAR PROSTHESIS
K833175 · KWY
Orthopedic · 94d
Cleared Sep 29, 1983
DOSIMETRY RELEASE OF RADIATION STERILIZ
K831512 · JDK
Orthopedic · 140d
Cleared Jul 28, 1983
KENNEDY TIBIAL COMPONENT
K831513 · HSX
Orthopedic · 77d
Cleared Jun 24, 1983
MILWAUKEE AUSTIN MOORE TOTAL HIP
K830314 · JDI
Orthopedic · 144d
Cleared May 25, 1983
CFE TOTAL HIP FEMORAL COMPONENT
K830313 · JDI
Orthopedic · 114d
Cleared May 16, 1983
LUS ACETABULAR COMPONENT
K830209 · JDI
Orthopedic · 112d
Cleared Mar 17, 1983
DOSIMETRY RELEASE OF RADIATION STERIL.
K823059
Orthopedic · 150d

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