FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Restrata Soft Tissue Reinforcement (STR)
K Number: K251224
·
Decision Jun 20, 2025
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
7
Review Days
60
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Basic Information
- Device Name
- Restrata Soft Tissue Reinforcement (STR)
- K Number
- K251224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acera Surgical, Inc.
- Date Received
- April 21, 2025
- Decision Date
- June 20, 2025
- Product Code
- OXF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXF), ordered by most recent decision date.
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Other Clearances by Acera Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K223725 | Restrata® MiniMatrix | May 18, 2023 | Substantially Equivalent |
| K193583 | Restrata® | Sep 25, 2020 | Substantially Equivalent |
| K172603 | Cerafix Dura Substitute | Nov 27, 2017 | Substantially Equivalent |
| K170300 | Restrata Wound Matrix | Apr 26, 2017 | Substantially Equivalent |
| K161278 | Cerafix Dura Substitute | Aug 8, 2016 | Substantially Equivalent |
| K153613 | Cerafix Dura Substitute | Mar 16, 2016 | Substantially Equivalent |