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FDA 510(k) Applications Submitted by PIEDAD PENA
FDA 510(k) Number
Submission Date
Device Name
Applicant
K130412
02/19/2013
OSTEOMED EXTREMIFUSE SYSTEM
OSTEOMED
K080694
03/11/2008
OSTEOMED MODULAR LOCKING FIXATION SYSTEM
OSTEOMED L.P.
K111176
04/27/2011
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
OSTEOMED L.P.
K121304
05/01/2012
OSTEOMED CRANIAL DISTRACTION SYSTEM
OSTEOMED
K151195
05/04/2015
OsteoMed IMF Screw
OSTEOMED
K152145
08/03/2015
OsteoMed ExtremiLOCK Wrist Plating System
OSTEOMED
K062851
09/25/2006
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
OSTEOMED L.P.
K123207
10/12/2012
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
OSTEOMED LP
K073065
10/30/2007
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
OSTEOMED L.P.
K123885
12/18/2012
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
OSTEOMED LP
K063792
12/22/2006
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
OSTEOMED L.P.
K131851
06/21/2013
OSTEOMED NEURO RONGEUR
OSTEOMED
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