ComposiTCP 30 flat head
by S.B.M 4 variants
ComposiTCP 30 flat head (905224) is a Class II device made by S.B.M, cleared under FDA 510(k) K122228 on 3 Oct 2012 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2015 (UDI-DI 03760154006897), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03760154006897 | Date23 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122228 | Date3 Oct 2012 | StatusActive |
Official records
- AccessGUDID record 03760154006897
- FDA 510(k) database K122228
- FDA 510(k) database K061262
Across registries
- FDA 510(k) K122228 decided 3 Oct 2012 Active
- FDA GUDID UDI-DI 03760154006897 listed 23 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K061262
- Cleared FDA 510(k) K122228
- Listed FDA GUDID 03760154006897
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ComposiTCP
- Generic name
- Bioabsorbable orthopaedic bone screw
- Model / Ref / Catalog
- ComposiTCP 30 flat head, 905224
- Primary DI / UDI-DI
- 03760154006897
- FDA product code
- MAI
- GMDN term
- Bioabsorbable orthopaedic bone screw
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Size
- Outer Diameter — 11 MillimeterLength — 35 Millimeter
Similar devices in this category
Other devices filed under Bioabsorbable orthopaedic bone screw.