METRX SYSTEM
FDA 510(k) clearance K993021 · decided 1999-11-10
Clearance details
- K-number
- K993021
- Device name
- METRX SYSTEM
- Applicant
- Surgical Navigation Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-08
- Decision date
- 1999-11-10
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Broomfield, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Surgical Navigation Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016. recall (Z-0991-05) | Warsaw Orthopedic, Inc. | 2005-07-13 |
| Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018. recall (Z-0992-05) | Warsaw Orthopedic, Inc. | 2005-07-13 |
| Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030. recall (Z-0993-05) | Warsaw Orthopedic, Inc. | 2005-07-13 |