Altus Spine HA Pedicle Screw System 811-7560HA
by Altus Spine
Listed
Valid until
Not applicable
FDA recalls
None foundDocuments
None
Trust
Unverified
Overview
Unlock the full potential of your spine with our innovative Altus Spine HA Pedicle Screw System. Designed for precise and reliable spinal fixation, this device features a unique hybrid design that combines the benefits of polyaxial screws with a durable HA coating. With its easy-to-use interface and robust manufacturing process, you can trust that your patients will receive safe and effective treatment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00843210157047 | Date4 Apr 2023 | StatusListed |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Altus Spine HA Pedicle Screw System
- Generic Name
- Spinal bone screw, non-bioabsorbable
- Model / Reference
- 811-7560HA
- Primary DI / UDI-DI
- 00843210157047
- 510(k) Number
- FDA Product Code
- NKB, KWQ
- GMDN Term
- Spinal bone screw, non-bioabsorbable
- Device Class
- Class II
- Regulation Number
- 888.3070, 888.3060
- GUDID distribution status
- In Commercial Distribution
Other devices from Altus Spine
Properties
Other properties (6)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No