Juliet® Ti LL Lumbar Interbody Device
FDA 510(k) clearance K190877 · decided 2019-05-29
Clearance details
- K-number
- K190877
- Device name
- Juliet® Ti LL Lumbar Interbody Device
- Applicant
- Spineart
- Decision
- Substantially Equivalent
- Date received
- 2019-04-04
- Decision date
- 2019-05-29
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Plan Les Ouates, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT recall (Z-1426-2023) | SPINEART SA | 2023-04-24 |