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
26-50 of 386
Cleared Jan 25, 2017
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
K161273 · MBB
Orthopedic · 265d
Cleared Nov 03, 2016
Persona Partial Knee System
K161592 · HSX
Orthopedic · 147d
Cleared Oct 12, 2016
Ulna Plating System
K162424 · HRS
Orthopedic · 43d
Cleared Sep 08, 2016
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166 · MBB
Orthopedic · 135d
Cleared Jun 16, 2016
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K160071 · MBB
Orthopedic · 155d
Cleared May 26, 2016
G7 Dual Mobility System, Active Articulation System
K161190 · LPH
Orthopedic · 29d
Cleared May 10, 2016
Vanguard XP Knee System
K153657 · MBH
Orthopedic · 141d
Cleared Mar 09, 2016
Biomet Variable Pitch Compression Screw System
K160058 · HWC
Orthopedic · 57d
Cleared Oct 14, 2015
OSS/Arcos IM Total Femur Rod
K152621 · JDI
Orthopedic · 30d
Cleared Oct 06, 2015
Arcos One-piece Femoral Revision System
K151603 · LPH
Orthopedic · 116d
Cleared Jul 16, 2015
Refobacin Bone Cement R
K150850 · MBB
Orthopedic · 107d
Cleared Jun 10, 2015
Affixus Tibial Nailing System
K150867 · HSB
Orthopedic · 70d
Cleared May 01, 2015
G7 Dual Mobility System
K150522 · LPH
Orthopedic · 60d
Cleared Mar 25, 2015
Echo Bi-Metric Microplasty Line Extension
K150503 · LPH
Orthopedic · 27d
Cleared Feb 12, 2015
Vanguard 360 Revision Knee System
K143192 · JWH
Orthopedic · 98d
Cleared Feb 10, 2015
G7 Freedom and Offset Liners, Freedom Head, Size 32
K142882 · LPH
Orthopedic · 131d
Cleared Jan 30, 2015
Prelude PF Patellae
K143543 · KRR
Orthopedic · 46d
Cleared Dec 23, 2014
Biomet Tibial trays
K142933 · JWH
Orthopedic · 75d
Cleared Dec 18, 2014
Echo Bi-Metric Microplasty Hip System
K143009 · LPH
Orthopedic · 59d
Cleared Dec 11, 2014
G7 OSSEOTI ACETUBLAR SHELLS
K140669 · LPH
Orthopedic · 268d
Cleared Oct 27, 2014
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · JDI
Orthopedic · 159d
Cleared Oct 27, 2014
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
K141407 · MBH
Orthopedic · 152d
Cleared Sep 15, 2014
Sirius Femoral Stem, Size 30A
K142295 · JDI
Orthopedic · 28d
Cleared Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653 · LZO
Orthopedic · 59d
Cleared Jul 30, 2014
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
K140883 · MBH
Orthopedic · 114d

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