METRx® System 9560100
by Medtronic Sofamor Danek, Inc.
METRx® System 9560100 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K002931 on 24 Nov 2000 and listed in FDA GUDID since 7 Mar 2019 (UDI-DI 00885074210353), active as of 23 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 | Number00885074210353 | Date7 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK002931 | Date24 Nov 2000 | StatusActive |
Official records
- AccessGUDID record 00885074210353
- FDA 510(k) database K002931
Across registries
- FDA 510(k) K002931 decided 24 Nov 2000 Active
- FDA GUDID UDI-DI 00885074210353 listed 7 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K002931
- Listed FDA GUDID 00885074210353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- METRx® System
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / reference
- 9560100
- Primary DI / UDI-DI
- 00885074210353
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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