Endobutton 7210085
Endobutton 7210085 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K980155 on 1 Apr 1998 and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010497017), 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 | Number03596010497017 | Date30 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK980155 | Date1 Apr 1998 | StatusActive |
Official records
- AccessGUDID record 03596010497017
- FDA 510(k) database K980155
Across registries
- FDA 510(k) K980155 decided 1 Apr 1998 Active
- FDA GUDID UDI-DI 03596010497017 listed 30 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K980155
- Listed FDA GUDID 03596010497017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Endobutton
- Generic name
- Tendon/ligament bone anchor, non-bioabsorbable
- Model / Ref / Catalog
- 7210085
- Primary DI / UDI-DI
- 03596010497017
- 510(k) Number
- FDA product code
- GAT, MBI
- GMDN term
- Tendon/ligament bone anchor, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 878.5000, 888.3040
- GUDID distribution status
- In Commercial Distribution
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