Modification to Caspian Spinal System
by K2M, Inc.
510(k) K093534
Modification to Caspian Spinal System is a Class II device made by K2M, Inc., cleared under FDA 510(k) K093534 on 16 Dec 2009, 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 | NumberK093534 | Date16 Dec 2009 | StatusActive |
Official records
- FDA 510(k) database K093534
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- Withdrawn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
Devices cleared under K093534
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CASPIAN® Spinal System 1101-535120 | 1101-535120 / 1101-535120 | 10888857015944 | Outer Diameter 3.5 mm; Length 120 mm | On the market |
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