510(k) K190877 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Juliet® Ti LL Lumbar Interbody Device
| Applicant | Spineart, Plan Les Ouates, CH |
| Decision | Substantially Equivalent, May 29, 2019 |
| Received | Apr 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190877
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2023 | SPINEART SA JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 0 Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.