510(k) K142148 ยท JDR Staple, Fixation, Bone
ORTHOHELIX STAPLE SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Medina OH, US |
| Decision | Substantially Equivalent, Aug 21, 2014 |
| Received | Aug 5, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142148
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.