The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Roi-a Interbody Fusion System.
| Device ID | K110327 |
| 510k Number | K110327 |
| Device Name: | LDR SPINE ROI-A INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | Maritza Elias |
| Correspondent | Maritza Elias LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-03 |
| Decision Date | 2011-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662663014472 | K110327 | 000 |
| 03662663012751 | K110327 | 000 |