Medical Device Manufacturer · US , Addison , TX

Osteomed LP - FDA 510(k) Cleared Devices

29 submissions · 29 cleared · Since 2003
29
Total
29
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteomed LP Orthopedic
16 devices
1-16 of 16
Cleared Feb 24, 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · HRS
Orthopedic · 84d
Cleared Jun 18, 2013
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
K131445 · HRS
Orthopedic · 29d
Cleared Nov 29, 2012
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
K123207 · MAX
Orthopedic · 48d
Cleared Apr 24, 2012
OSTEOMED WRIST PLATING SYSTEM
K120015 · HRS
Orthopedic · 112d
Cleared Oct 07, 2011
OSTEOMED HAND FUSION SYSTEM
K111419 · HRS
Orthopedic · 140d
Cleared Sep 30, 2010
PRIMALOK FACET FIXATION SYSTEM
K102438 · MRW
Orthopedic · 35d
Cleared Aug 17, 2010
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354 · KWP
Orthopedic · 186d
Cleared Sep 10, 2009
OSTEOMED FOOT PLATING SYSTEM
K091614 · HRS
Orthopedic · 99d
Cleared Jul 02, 2009
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
K090522 · HRS
Orthopedic · 126d
Cleared Aug 01, 2008
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876 · KWD
Orthopedic · 30d
Cleared Feb 21, 2008
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
K073065 · KWD
Orthopedic · 114d
Cleared Jul 30, 2007
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
K071105 · HRS
Orthopedic · 102d
Cleared Mar 02, 2007
OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
K063298 · HWC
Orthopedic · 121d
Cleared Oct 31, 2006
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
K062863 · HWC
Orthopedic · 36d
Cleared Jun 02, 2006
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536 · KWD
Orthopedic · 94d
Cleared Aug 22, 2003
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155 · HWC
Orthopedic · 133d
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