FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cerafix Dura Substitute
K Number: K172603
·
Decision Nov 27, 2017
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
42
Applicant Total
7
Review Days
89
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Basic Information
- Device Name
- Cerafix Dura Substitute
- K Number
- K172603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acera Surgical, Inc.
- Date Received
- August 30, 2017
- Decision Date
- November 27, 2017
- Product Code
- GXQ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXQ | Dura Substitute | FDA class 2 | Neurology |
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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 |
| K223725 | Restrata® MiniMatrix | May 18, 2023 | Substantially Equivalent |
| K193583 | Restrata® | Sep 25, 2020 | 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 |