FDA 510(k) Application Details - K925872

Device Classification Name Screw, Fixation, Bone

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510(K) Number K925872
Device Name Screw, Fixation, Bone
Applicant NORTHO ORTHOPEDICS
2001 EAST LOHMAN #311
LAS CRUCES, NM 88001 US
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Contact H.C. NORRIS
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 11/19/1992
Decision Date 03/22/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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