510(k) K092721 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
ALIGN RADIAL HEAD SYSTEM
| Applicant | Skeletal Dynamics, LLC, Shelton CT, US |
| Decision | Substantially Equivalent, Aug 3, 2010 |
| Received | Sep 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Skeletal Dynamics Align Radial Stems, Prosthesis, Elbow, Hemi
Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/o Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.