FDA 510(k) Application Details - K060071

Device Classification Name Screw, Fixation, Bone

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510(K) Number K060071
Device Name Screw, Fixation, Bone
Applicant NEXA ORTHOPEDICS, INC.
10675 SORRENTO VALLEY ROAD
SUITE 100
SAN DIEGO, CA 92121 US
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Contact LOUISE M FOCHT
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 01/09/2006
Decision Date 01/26/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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