STRYKER REMOTE SURGICAL PLANNING SYSTEM
FDA 510(k) clearance K004027 · decided 2001-01-24
Clearance details
- K-number
- K004027
- Device name
- STRYKER REMOTE SURGICAL PLANNING SYSTEM
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2000-12-27
- Decision date
- 2001-01-24
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7 recall (Z-0005-2007) | Stryker Instruments Div. of Stryker Corporation | 2006-10-03 |
| Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, S recall (Z-0006-2007) | Stryker Instruments Div. of Stryker Corporation | 2006-10-03 |
| Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 recall (Z-0007-2007) | Stryker Instruments Div. of Stryker Corporation | 2006-10-03 |
| Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, recall (Z-0008-2007) | Stryker Instruments Div. of Stryker Corporation | 2006-10-03 |