Restrata Soft Tissue Reinforcement (STR)— 510(k) K251224
Substantially EquivalentAcera Surgical, Inc.
FDA 510(k) clearance K251224 for Restrata Soft Tissue Reinforcement (STR), Substantially Equivalent on 2025-06-20. Applicant: Acera Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Acera Surgical, Inc.
- Product code
- Code OXF
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code OXF
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