FDA 510(k) Application Details - K023013

Device Classification Name Screw, Fixation, Bone

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510(K) Number K023013
Device Name Screw, Fixation, Bone
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact ALISA MILLER
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 09/10/2002
Decision Date 02/26/2003
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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