Restrata Soft Tissue Reinforcement (STR)— 510(k) K251224

Substantially Equivalent

Acera Surgical, Inc.

FDA 510(k) clearance K251224 for Restrata Soft Tissue Reinforcement (STR), Substantially Equivalent on 2025-06-20. Applicant: Acera Surgical, Inc..

Clearance details

Applicant: Acera Surgical, Inc.
Product code: Code OXF
Advisory panel: General, Plastic Surgery
Date received: 2025-04-21
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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