Syntec OS Spinal Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101971 FDA 510(k)
- FDA Product Code
- NKB 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 Syntec OS Spinal Fixation System is an implantable internal spinal fixation system intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion. It consists of components such as small connecting bands or rods with grooves or holes to accommodate screw heads and primary rods, as well as threaded implantable rods with screw heads and drives designed to be screwed into the spine to hold correction or stabilization devices to bone.
The system is supplied as a sterile, single-use implantable device for use in surgical settings. It received FDA 510(k) clearance (K101971) on March 25, 2011, and is classified under product code NKB with advisory committee review in orthopedics (OR). The device is manufactured by Syntec Scientific Corp. and is intended for spinal stabilization procedures as specified in its authorization documentation.
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. Sources consulted: SYNTEC OS SPINAL FIXATION SYSTEM (K101971) — FDA 510 (k) | Innolitics, DEVICE: Syntec OS Spinal Fixation System (04716873713751), DEVICE: Syntec OS Spinal Fixation System (04719873284986)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101971 | Class II | Active |
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Manufacturer
- Manufacturer
- Syntec Scientific Corp.
Sources (1)
- FDA 510(k) K101971 24 fields · synced Sep 23, 2026