Solstice CCI
510(k) K200896
Solstice CCI is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K200896 on 28 Apr 2020, 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 | NumberK200896 | Date28 Apr 2020 | StatusActive |
Official records
- FDA 510(k) database K200896
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKG
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3075
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent