SUPRAFOIL Code F-LSS-035
SUPRAFOIL Code F-LSS-035 is a Class II device made by S. Jackson, Inc., cleared under FDA 510(k) K973379 on 25 Sep 1997 and listed in FDA GUDID since 9 Aug 2017 (UDI-DI 00816848022926), active as of 22 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 | Number00816848022926 | Date9 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK973379 | Date25 Sep 1997 | StatusActive |
Official records
- AccessGUDID record 00816848022926
- FDA 510(k) database K973379
Across registries
- FDA 510(k) K973379 decided 25 Sep 1997 Active
- FDA GUDID UDI-DI 00816848022926 listed 9 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K973379
- Listed FDA GUDID 00816848022926
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Suprafoil
- Generic name
- Orbital wall/rim prosthesis
- Model / Ref / Catalog
- Code F-LSS-035
- Primary DI / UDI-DI
- 00816848022926
- 510(k) Number
- FDA product code
- FTM
- GMDN term
- Orbital wall/rim prosthesis
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
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