MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM
FDA 510(k) clearance K090507 · decided 2009-06-25
Clearance details
- K-number
- K090507
- Device name
- MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM
- Applicant
- Ldr Spine USA
- Decision
- Substantially Equivalent
- Date received
- 2009-02-25
- Decision date
- 2009-06-25
- Days to decision
- 120 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Ldr Spine USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |