Sierra™ 50-6060
by SeaSpine Orthopedics Corporation
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
The Sierra™ is a high-quality, advanced surgical drill bit designed for orthopedic procedures. This single-use cannulated surgical drill bit is used to provide stabilization of the spine during spinal fusion surgery, allowing for biological process of spinal fusion to occur. With its proprietary design and materials, this device offers superior stability and comfort, making it an ideal choice for surgeons and patients alike.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889981043094 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062934 | Date16 Nov 2006 | StatusActive |
Official records
- AccessGUDID record 10889981043094
- FDA 510(k) database K062934
Across registries
- FDA 510(k) K062934 decided 16 Nov 2006 Active
- FDA GUDID UDI-DI 10889981043094 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K062934
- Listed FDA GUDID 10889981043094
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- Withdrawn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
- 50-6060
- Primary DI / UDI-DI
- 10889981043094
- 510(k) Number
- FDA product code
- KWP, MNI
- GMDN term
- Cannulated surgical drill bit, single-use
- Device class
- Class II
- Regulation number
- 888.3050, 888.3070
- 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.