← Back to catalogue
Cranioclamp Bioabsorbable Cranial Bone Flap Fixation System
FDA 510(k)Class II (US FDA 510(k))
510(k) K071138
by Prosurg Inc
Identifiers
- 510(k) Number
- K071138 FDA 510(k)
- FDA Product Code
- GXR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5250 FDA 510(k)
- Regulation Number
- 882.5250 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cranioclamp Bioabsorbable Cranial Bone Flap Fixation System by Prosurg Inc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071138 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prosurg Inc
- FDA Applicant
- Prosurg, Inc.
Sources (1)
- FDA 510(k) K071138 24 fields · synced Jun 19, 2026