FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Restrata® MiniMatrix
K Number: K223725
·
Decision May 18, 2023
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
7
Review Days
156
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Basic Information
- Device Name
- Restrata® MiniMatrix
- K Number
- K223725
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acera Surgical, Inc.
- Date Received
- December 13, 2022
- Decision Date
- May 18, 2023
- Product Code
- QSZ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| QSZ | Absorbable Synthetic Wound Dressing | FDA unclassified | Unknown |
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Other Clearances by Acera Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Jun 20, 2025 | 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 |