510(k) K183618 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Revolution Radial Head
| Applicant | Ignite Orthopedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 17, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2022 | Synthes (USA) Products LLC Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diamet Open, Classified |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.