Sierra™ 50-3516
by SeaSpine Orthopedics Corporation
Sierra™ 50-3516 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K062934 on 16 Nov 2006 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10889981042417), 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 | Number10889981042417 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062934 | Date16 Nov 2006 | StatusActive |
Official records
- AccessGUDID record 10889981042417
- FDA 510(k) database K062934
Across registries
- FDA 510(k) K062934 decided 16 Nov 2006 Active
- FDA GUDID UDI-DI 10889981042417 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K062934
- Listed FDA GUDID 10889981042417
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sierra™
- Generic name
- Cannulated surgical drill bit, single-use
- Model / Ref / Catalog
- 50-3516
- Primary DI / UDI-DI
- 10889981042417
- 510(k) Number
- FDA product code
- MNI, KWP
- GMDN term
- Cannulated surgical drill bit, single-use
- Device class
- Class II
- Regulation number
- 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Cannulated surgical drill bit, single-use.