510(k) K120115 ยท LLZ System, Image Processing, Radiological
ORTHOSIZE
| Applicant | Orthosize, LLC, Philedelphia PA, US |
| Decision | Substantially Equivalent, Mar 14, 2012 |
| Received | Jan 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2017 | Zimmer Biomet, Inc. Orthosize Templating Version 1.2.6
Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.