9074122
by Medtronic Sofamor Danek, Inc.
9074122 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K040422 on 19 Mar 2004 and listed in FDA GUDID since 30 Jul 2015 (UDI-DI 00721902478444), 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 | Number00721902478444 | Date30 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040422 | Date19 Mar 2004 | StatusActive |
Official records
- AccessGUDID record 00721902478444
- FDA 510(k) database K040422
Across registries
- FDA 510(k) K040422 decided 19 Mar 2004 Active
- FDA GUDID UDI-DI 00721902478444 listed 30 Jul 2015 Listed
Timeline
- Cleared FDA 510(k) K040422
- Listed FDA GUDID 00721902478444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / reference
- 9074122
- Primary DI / UDI-DI
- 00721902478444
- 510(k) Number
- FDA product code
- MQP
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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