510(k) K060428 ยท HWC Screw, Fixation, Bone
CSS CANNULATED SCREW SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Mar 7, 2006 |
| Received | Feb 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060428
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031 Terminated |
HWX | None listed |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021 Terminated |
HWX | None listed |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 Terminated |
HWX | None listed |
| Apr 6, 2010 | Orthohelix Surgical Designs Inc MaxTorque Cannulated Screw Model # MSD-010-55-060S Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.