← Back to catalogue
Modification To: Vertefix Pedicle Screw Spinal System
FDA 510(k)Class II (US FDA 510(k))
510(k) K080075
Identifiers
- 510(k) Number
- K080075 FDA 510(k)
- FDA Product Code
- MNI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Modification To: Vertefix Pedicle Screw Spinal System by Elite Surgical Supplies (pty) Ltd — Class II — FDA_510K — listed in FDA 510(k)
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 | K080075 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elite Surgical Supplies (pty) Ltd
- FDA Applicant
- Elite Surgical Supplies (Pty), Ltd.
Sources (1)
- FDA 510(k) K080075 24 fields · synced Jun 18, 2026