Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
FDA 510(k) clearance K153495 · decided 2016-03-31
Clearance details
- K-number
- K153495
- Device name
- Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
- Applicant
- Ldr Spine USA
- Decision
- Substantially Equivalent
- Date received
- 2015-12-07
- Decision date
- 2016-03-31
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-RO recall (Z-0045-2017) | LDR Spine USA, Inc. | 2016-10-05 |