FDA 510(k) Application Details - K232683

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K232683
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant Stryker Endoscopy
5900 Optical Ct.
San Jose, CA 95138 US
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Contact Madison Mutchler
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 09/01/2023
Decision Date 10/24/2023
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

FDA Source Information for K232683


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