Osteotomy Wedge System— 510(k) K252254

Substantially Equivalent

Sinaptic Surgical

FDA 510(k) clearance K252254 for Osteotomy Wedge System, Substantially Equivalent on 2025-10-17. Applicant: Sinaptic Surgical.

Clearance details

Applicant: Sinaptic Surgical
Product code: Code PLF
Advisory panel: Orthopedic
Date received: 2025-07-21
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Slat Lake City, UT, US

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