SUPERCABLE GRIP AND PLATE SYSTEM
FDA 510(k) clearance K072250 · decided 2007-11-09
Clearance details
- K-number
- K072250
- Device name
- SUPERCABLE GRIP AND PLATE SYSTEM
- Applicant
- Kinamed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-13
- Decision date
- 2007-11-09
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 Th recall (Z-2588-2011) | Kinamed Inc | 2011-06-17 |