The following data is part of a premarket notification filed by Republic Spine Llc with the FDA for Republic Spine Restore Intervertebral Body Fusion System.
| Device ID | K190398 |
| 510k Number | K190398 |
| Device Name: | Republic Spine Restore Intervertebral Body Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Republic Spine LLC 350 Camino Gardens Blvd Suite 103 Boca Raton, FL 33432 |
| Contact | James Doulgeris |
| Correspondent | James Doulgeris Republic Spine LLC 350 Camino Gardens Blvd Suite 103 Boca Raton, FL 33432 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07511002228S1106P0 | K190398 | 000 |