CSS CANNULATED SCREW SYSTEM
FDA 510(k) clearance K060428 · decided 2006-03-07
Clearance details
- K-number
- K060428
- Device name
- CSS CANNULATED SCREW SYSTEM
- Applicant
- Orthohelix Surgical Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-21
- Decision date
- 2006-03-07
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031 recall (Z-0466-2011) | Orthohelix Surgical Designs Inc | 2010-11-26 |
| CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021 recall (Z-0467-2011) | Orthohelix Surgical Designs Inc | 2010-11-26 |
| CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 recall (Z-0468-2011) | Orthohelix Surgical Designs Inc | 2010-11-26 |
| MaxTorque Cannulated Screw Model # MSD-010-55-060S recall (Z-1250-2010) | Orthohelix Surgical Designs Inc | 2010-04-06 |