Tc-100 71176011
Tc-100 71176011 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K123055 on 25 Jan 2013 and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 03596010302700), 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 | Number03596010302700 | Date25 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123055 | Date25 Jan 2013 | StatusActive |
Official records
- AccessGUDID record 03596010302700
- FDA 510(k) database K123055
Across registries
- FDA 510(k) K123055 decided 25 Jan 2013 Active
- FDA GUDID UDI-DI 03596010302700 listed 25 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K123055
- Listed FDA GUDID 03596010302700
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tc-100
- Generic name
- Fluted surgical drill bit, single-use
- Model / Ref / Catalog
- 71176011
- Description
- 1.1MM DRILL BIT QUICK COUPLING 60/35MM STERILE
- Primary DI / UDI-DI
- 03596010302700
- 510(k) Number
- FDA product code
- HRS
- GMDN term
- Fluted surgical drill bit, single-use
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
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