MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
FDA 510(k) clearance K043088 · decided 2005-01-05
Clearance details
- K-number
- K043088
- Device name
- MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
- Applicant
- Medtronic Surgical Navigation Technologies
- Decision
- Substantially Equivalent
- Date received
- 2004-11-08
- Decision date
- 2005-01-05
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AxiEM EM Knee Kit, and associated workstation. recall (Z-0718-06) | Medtronic Navigation, Inc | 2006-04-07 |