510(k) K073624 ยท HRS Plate, Fixation, Bone
MODULAR FOOT SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Mar 20, 2008 |
| Received | Dec 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073624
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2010 | Orthohelix Surgical Designs Inc Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256.
Intended as a guide to normal healing and are not intended to replace normal b Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.