The following data is part of a premarket notification filed by Accel Spine with the FDA for Spinal Intervertebral Body Fixation Orthosis.
| Device ID | K132366 |
| 510k Number | K132366 |
| Device Name: | SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ACCEL SPINE 14901 QUORUM DR. STE. 125 Dallas, TX 75254 |
| Contact | Aekta Patel |
| Correspondent | Aekta Patel ACCEL SPINE 14901 QUORUM DR. STE. 125 Dallas, TX 75254 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2013-09-03 |
| Summary: | summary |