Medical Device Manufacturer · US , Warsaw , IN

Biomet Manufacturing Corp - FDA 510(k) Cleared Devices

93 submissions · 93 cleared · Since 2004
93
Total
93
Cleared
0
Denied
93 devices
76-93 of 93
Cleared Jan 18, 2007
MICROPLASTY TIBIAL TRAYS
K063732 · JWH
Orthopedic · 31d
Cleared Dec 11, 2006
MODULAR HYBRID GLENOID
K060694 · KWS
Orthopedic · 271d
Cleared Dec 08, 2006
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
K062997 · LZO
Orthopedic · 67d
Cleared Oct 31, 2006
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
K062995 · KWA
Orthopedic · 29d
Cleared Oct 31, 2006
ALTRA PRESS-FIT HIP SYSTEM
K063002 · KWA
Orthopedic · 29d
Cleared Oct 19, 2006
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
K061681 · HRY
Orthopedic · 126d
Cleared Jul 27, 2006
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
K061423 · KWA
Orthopedic · 65d
Cleared Jun 12, 2006
VERSA-DIAL HUMERAL HEAD PROSTHESIS
K060716 · MBF
Orthopedic · 87d
Cleared May 30, 2006
COMPREHENSIVE PRIMARY SHOULDER STEMS
K060692 · MBF
Orthopedic · 76d
Cleared May 25, 2006
VANGUARD REMOVABLE MOLDED POLY TIBIA
K060525 · JWH
Orthopedic · 87d
Cleared Apr 28, 2006
POROUS TITANIUM ACETABULAR SHELLS
K052996 · LPH
Orthopedic · 185d
Cleared Mar 30, 2006
VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS
K060303 · MBH
Orthopedic · 52d
Cleared Mar 21, 2006
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP...
K060121 · HAW
Neurology · 63d
Cleared Feb 15, 2006
OSS-BODIES PROXIMAL TIBIAL SLEEVE
K060131 · KRO
Orthopedic · 28d
Cleared Dec 06, 2005
POROUS TITANIUM ACETABULAR AUGMENTS
K052888 · KWA
Orthopedic · 54d
Cleared Jan 28, 2005
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
K042321 · KWT
Orthopedic · 155d
Cleared Sep 08, 2004
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL...
K041872 · MBH
Orthopedic · 61d
Cleared Jul 01, 2004
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
K041466 · JWH
Orthopedic · 29d

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