ELEVATE™ Spinal System 8657001
by Medtronic Sofamor Danek, Inc. 2 variants
ELEVATE™ Spinal System 8657001 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K142559 on 9 Jun 2015 and listed in FDA GUDID since 25 Jun 2016 (UDI-DI 00643169432178), 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 | GUDID listing | Number00643169432178 | Date25 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142559 | Date9 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 00643169432178
- FDA 510(k) database K142559
Across registries
- FDA 510(k) K142559 decided 9 Jun 2015 Active
- FDA GUDID UDI-DI 00643169432178 listed 25 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K142559
- Listed FDA GUDID 00643169432178
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ELEVATE™ Spinal System
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / reference
- 8657001
- Primary DI / UDI-DI
- 00643169432178
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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