510(k) K191353 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
COMET Lumbar Interbody Fusion Cage
| Applicant | Baui Biotech Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Apr 14, 2020 |
| Received | May 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191353
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.