The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Cervical Interbody Fusion System.
| Device ID | K091088 |
| 510k Number | K091088 |
| Device Name: | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-15 |
| Decision Date | 2009-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662663022163 | K091088 | 000 |
| 03662663021890 | K091088 | 000 |
| 03662663021944 | K091088 | 000 |
| 03662663021968 | K091088 | 000 |
| 03662663022002 | K091088 | 000 |
| 03662663022026 | K091088 | 000 |
| 03662663022071 | K091088 | 000 |
| 03662663022095 | K091088 | 000 |
| 03662663022149 | K091088 | 000 |
| 03662663021876 | K091088 | 000 |