FDA 510(k) Application Details - K161032

Device Classification Name Orthosis, Cervical Pedicle Screw Spinal Fixation

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510(K) Number K161032
Device Name Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant ULRICH GMBH & CO. KG
BUCHBRUNNENWEG 12
ULM 89081 DE
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Contact Christoph Ulrich
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Regulation Number 000.0000

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Classification Product Code NKG
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Date Received 04/13/2016
Decision Date 12/22/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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