HIP MODULE FOR THE STEALTHSTATION SYSTEM
FDA 510(k) clearance K021980 · decided 2002-11-19
Clearance details
- K-number
- K021980
- Device name
- HIP MODULE FOR THE STEALTHSTATION SYSTEM
- Applicant
- Medtronic Surgical Navigation Technologies
- Decision
- Substantially Equivalent
- Date received
- 2002-06-17
- Decision date
- 2002-11-19
- Days to decision
- 155 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 |
|---|---|---|
| Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 800 recall (Z-0923-2010) | Medtronic Navigation, Inc | 2010-03-03 |
| Fix pins associated with Stealth Station Treatment Guidance Platform recall (Z-0231-04) | Medtronic Surgical Navigation Tech, Inc | 2003-12-17 |