The following data is part of a premarket notification filed by Accel Spine with the FDA for Cezanne Ii Interbody Fusion System.
| Device ID | K131981 |
| 510k Number | K131981 |
| Device Name: | CEZANNE II INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ACCEL SPINE 14901 QUORUM DR. STE. 125 Dallas, TX 75254 |
| Contact | Lisa Peterson |
| Correspondent | Lisa Peterson ACCEL SPINE 14901 QUORUM DR. STE. 125 Dallas, TX 75254 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2013-10-09 |
| Summary: | summary |