510(k) K180227 ยท PGM Growing Rod System
Polaris Spinal Growth System
| Applicant | Zimmer Biomet Spine, Inc., Westminister CO, US |
| Decision | Substantially Equivalent, Mar 15, 2018 |
| Received | Jan 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180227
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.