The following data is part of a premarket notification filed by Coalign Innovations, Inc. with the FDA for Acculif Tl-peek Cage.
| Device ID | K123281 |
| 510k Number | K123281 |
| Device Name: | ACCULIF TL-PEEK CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | COALIGN INNOVATIONS, INC. 31 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton COALIGN INNOVATIONS, INC. 31 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-22 |
| Decision Date | 2013-01-23 |
| Summary: | summary |