Metrx System
by Medtronic Sofamor Danek, Inc.
510(k) K002931
Metrx System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K002931 on 24 Nov 2000, 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 | NumberK002931 | Date24 Nov 2000 | StatusActive |
Official records
- FDA 510(k) database K002931
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K002931
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 | |||
|---|---|---|---|---|
| METRx® System 9560100 | 9560100 | 00885074210353 | — | On the market |
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