510(k) K082574 ยท HWC Screw, Fixation, Bone
MAXTORQUE MINI CANNULATED SCREW SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Dec 8, 2008 |
| Received | Sep 5, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2012 | Orthohelix Surgical Designs Inc OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and Terminated |
HWC | None listed |
| Oct 9, 2012 | Orthohelix Surgical Designs Inc OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and Terminated |
HWC | None listed |
| Apr 22, 2010 | Orthohelix Surgical Designs Inc Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38.
Used to drill or cut bone prior to implantation of screws Terminated |
HTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.