510(k) K101962 ยท HRS Plate, Fixation, Bone
MINI MAXLOCK EXTREME PLATING SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Medina OH, US |
| Decision | Substantially Equivalent, Sep 27, 2010 |
| Received | Jul 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2011 | Orthohelix Surgical Designs Inc Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901,
Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusion Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.