FDA 510(k) Application Details - K011319

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K011319
Device Name Pin, Fixation, Threaded
Applicant Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA, CA 95051-4085 US
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Contact RYAN YEARSLEY
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 05/01/2001
Decision Date 07/20/2001
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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