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510(k) K230874

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath by Suzhou Endophix Co., Ltd. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2023
Date Received
March 30, 2023
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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