The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Ti-diagon Oblique Tlif.
| Device ID | K172064 |
| 510k Number | K172064 |
| Device Name: | Ti-Diagon Oblique TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Camber Spine Technologies 418 E. Lancaster Avenue Wayne, PA 19087 |
| Contact | Daniel Pontecorvo |
| Correspondent | Justin Eggleton MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-07 |
| Decision Date | 2017-09-15 |
| Summary: | summary |