The following data is part of a premarket notification filed by Republic Spine, L.l.c. with the FDA for Republic Spine Restore Cervical Interbody Fusion System.
| Device ID | K190889 |
| 510k Number | K190889 |
| Device Name: | Republic Spine Restore Cervical Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Republic Spine, L.L.C. 2424 N. Federal Hwy Boca Raton, FL 33431 |
| Contact | James Doulgeris |
| Correspondent | James Doulgeris Republic Spine, L.L.C. 2424 N. Federal Hwy Boca Raton, FL 33431 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-05 |
| Decision Date | 2019-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07511000508MP100 | K190889 | 000 |