Syntec OS Spinal Fixation System 853087
Syntec OS Spinal Fixation System 853087 is a Class II device made by Syntec Scientific Corp., listed in FDA GUDID since 5 Feb 2026 (UDI-DI 04719873287796), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719873287796 | Date5 Feb 2026 | StatusListed |
Official records
- AccessGUDID record 04719873287796
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Syntec OS Spinal Fixation System
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / Ref / Catalog
- 853087
- Primary DI / UDI-DI
- 04719873287796
- FDA product code
- KWP
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization