The following data is part of a premarket notification filed by Ldr Spine Usa Inc. with the FDA for Ldr Spine Cervical Interbody Fusion Systme-roi-c Lordotic Implants.
| Device ID | K113559 |
| 510k Number | K113559 |
| Device Name: | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Contact | Kiersten Soderman |
| Correspondent | Kiersten Soderman LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2011-12-29 |
| Summary: | summary |