Battalion Universal Spacer System
510(k) K143740
Battalion Universal Spacer System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K143740 on 22 May 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143740 | Date22 May 2015 | StatusActive |
Official records
- FDA 510(k) database K143740
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent