510(k) K111041 ยท HRS Plate, Fixation, Bone
MINI VARIABLE SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Medina OH, US |
| Decision | Substantially Equivalent, Jun 6, 2011 |
| Received | Apr 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111041
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.