510(k) K191212 ยท PGM Growing Rod System
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System
| Applicant | Medos International SARL, Lelocle, CH |
| Decision | Substantially Equivalent, Sep 24, 2019 |
| Received | May 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191212
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.