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510(k) K211502

Alpha Vent PEEK Suture Anchor by Stryker Endoscopy — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2021
Date Received
May 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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