Caspian Spinal System
510(k) K103232
Caspian Spinal System is a Class II device made by K2M, Inc., cleared under FDA 510(k) K103232 on 13 Jan 2011, 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 | NumberK103232 | Date13 Jan 2011 | StatusActive |
Official records
- FDA 510(k) database K103232
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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