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
201-225 of 386
Cleared Nov 03, 2000
BIOMET LATERAL TROCH PLATE
K003294 · JDW
Orthopedic · 14d
Cleared Nov 02, 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · JDW
Orthopedic · 27d
Cleared Oct 06, 2000
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · KWT
Orthopedic · 10d
Cleared Oct 04, 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772 · JWH
Orthopedic · 28d
Cleared Sep 19, 2000
ASCENT KNEE SYSTEM
K002678 · JWH
Orthopedic · 22d
Cleared Sep 19, 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · JWH
Orthopedic · 18d
Cleared Aug 31, 2000
RADIOLUCENT COLLES FRACTURE KIT
K001760 · LXT
Orthopedic · 83d
Cleared Aug 31, 2000
M2A 28MM RINGLOC LINER
K002379 · KWA
Orthopedic · 27d
Cleared Aug 17, 2000
GROSS FEMORAL COMPONENT
K001580 · MEH
Orthopedic · 87d
Cleared Aug 07, 2000
LACTOSORB PANELS AND FASTENERS
K984390 · HRS
Orthopedic · 608d
Cleared Jul 27, 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · JDI
Orthopedic · 15d
Cleared Jul 26, 2000
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350 · KRR
Orthopedic · 89d
Cleared Jul 20, 2000
TI-MAX PROTRUSIO CAGE
K001376 · JDI
Orthopedic · 80d
Cleared Jul 14, 2000
SAMARCO SPIDER PLATES
K001271 · KTW
Orthopedic · 85d
Cleared Jun 27, 2000
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683 · JDC
Orthopedic · 119d
Cleared Jun 22, 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978 · JWH
Orthopedic · 87d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760 · LPH
Orthopedic · 76d
Cleared May 18, 2000
METAL ON METAL ACETABULAR SYSTEM
K993438 · KWA
Orthopedic · 219d
Cleared Apr 27, 2000
ASCENT KNEE REVISION FEMORAL STEM
K001010 · JWH
Orthopedic · 29d
Cleared Apr 11, 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS...
K990830 · LPH
Orthopedic · 396d
Cleared Apr 06, 2000
PEDIATRIC FIXATION RODS
K000764 · JDS
Orthopedic · 28d
Cleared Mar 15, 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · LPH
Orthopedic · 27d
Cleared Feb 25, 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335 · LPH
Orthopedic · 22d
Cleared Feb 16, 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334 · LPH
Orthopedic · 13d
Cleared Feb 15, 2000
PLR SPLINED REVISION STEM
K994184 · LZO
Orthopedic · 67d

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