Caplox II Pedicle Screw System/Towerlox Pedicle Screw System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131538 FDA 510(k)
- FDA Product Code
- MNH 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)
The Caplox II Pedicle Screw System/Towerlox Pedicle Screw System is an orthopedic device used for spinal fixation. It consists of pedicle screws and associated components designed to stabilize the spine during surgical procedures.
This system is supplied as a sterile, single-use device and is not intended for MRI environments. It is authorized under FDA 510K clearance with product code MNH and was cleared on August 8, 2013.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131538 | Class II | Active |
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Manufacturer
- Manufacturer
- Captiva Spine
Sources (1)
- FDA 510(k) K131538 24 fields · synced Sep 23, 2026