TIMESH SYSTEM
FDA 510(k) clearance K974017 · decided 1998-01-16
Clearance details
- K-number
- K974017
- Device name
- TIMESH SYSTEM
- Applicant
- Sofamor Danek USA,Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-22
- Decision date
- 1998-01-16
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 80012 recall (Z-0849-06) | Medtronic Neurosurgery | 2006-05-06 |