ELEVATE™ Spinal System 8881028
by Medtronic Sofamor Danek, Inc.
ELEVATE™ Spinal System 8881028 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K172199 on 19 Sep 2017 (1 earlier submission) and listed in FDA GUDID since 30 Sep 2015 (UDI-DI 00643169430839), 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 | NumberK172199 | Date19 Sep 2017 | StatusActive |
| United States | GUDID listing | Number00643169430839 | Date30 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 00643169430839
- FDA 510(k) database K172199
- FDA 510(k) database K142559
Across registries
- FDA 510(k) K172199 decided 19 Sep 2017 Active
- FDA GUDID UDI-DI 00643169430839 listed 30 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K142559
- Listed FDA GUDID 00643169430839
- Cleared FDA 510(k) K172199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ELEVATE™ Spinal System
- Generic name
- Polymeric spinal interbody fusion cage
- Model / reference
- 8881028
- Primary DI / UDI-DI
- 00643169430839
- FDA product code
- MAX
- GMDN term
- Polymeric spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Width — 10.0 MillimeterHeight — 10.0 MillimeterLength — 28.0 Millimeter
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