Medical Device Manufacturer · US , Raynham , MA

Omni Life Science, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2006
21
Total
21
Cleared
0
Denied

FDA 510(k) cleared devices by Omni Life Science, Inc. Orthopedic

21 devices
1-21 of 21
Cleared Sep 25, 2019
OMNI TiN Coated Apex Knee™ System
K191765 · JWH
Orthopedic · 86d
Cleared Mar 10, 2016
OMNI Skirted Heads
K152919 · LZO
Orthopedic · 160d
Cleared Oct 08, 2013
APEX KNEE MODULAR TIBIA SYSTEM
K131472 · JWH
Orthopedic · 139d
Cleared Feb 29, 2012
APEX REVISION KNEE SYSTEMS
K112891 · JWH
Orthopedic · 152d
Cleared Jan 05, 2012
APEX ARC HIP STEM
K113242 · LPH
Orthopedic · 64d
Cleared Jul 13, 2011
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
K111062 · JWH
Orthopedic · 86d
Cleared Jun 27, 2011
APEX ARC HIP STEM
K111193 · LZO
Orthopedic · 60d
Cleared Jun 22, 2011
APEX PS KNEE SYSTEM - PS-C INSERT
K111184 · JWH
Orthopedic · 56d
Cleared Jun 16, 2011
APEX K1 HIP STEM
K110947 · LPH
Orthopedic · 73d
Cleared Mar 25, 2011
APEX PS KNEE SYSTEM
K102578 · JWH
Orthopedic · 198d
Cleared Sep 14, 2010
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
K101976 · LPH
Orthopedic · 63d
Cleared Jun 22, 2010
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
K101451 · LZO
Orthopedic · 28d
Cleared Apr 07, 2010
APEX ARC HIP STEM
K090845 · LZO
Orthopedic · 376d
Cleared Mar 29, 2010
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
K100555 · LPH
Orthopedic · 28d
Cleared Mar 05, 2010
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
K094017 · JWH
Orthopedic · 66d
Cleared Oct 23, 2009
INTERFACE ACETABULAR CUP LINERS
K092443 · LPH
Orthopedic · 74d
Cleared Feb 18, 2009
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM]...
K082468 · KWY
Orthopedic · 175d
Cleared May 23, 2008
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
K080842 · MBH
Orthopedic · 59d
Cleared Feb 27, 2008
APEX-LNK POLY ACETABULAR CUP LINERS
K073150 · LPH
Orthopedic · 111d
Cleared Aug 24, 2006
MONOBLOCK PRESS-FIT HIP STEM
K060072 · LPH
Orthopedic · 227d
Cleared Jun 15, 2006
APEX KNEE SYSTEM
K060192 · JWH
Orthopedic · 141d
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