510(k) K102156 ยท HRS Plate, Fixation, Bone
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
| Applicant | Orthohelix Surgical Designs, Inc., Medina OH, US |
| Decision | Substantially Equivalent, Sep 30, 2010 |
| Received | Jul 30, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Orthohelix Surgical Designs Inc MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY.
Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.