510(k) K190563 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
| Applicant | Solco Biomedical Co., Ltd., Pyeongtaek, KR |
| Decision | Substantially Equivalent, Sep 18, 2019 |
| Received | Mar 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190563
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.