The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Bacfix Spinal Fixation System.
| Device ID | K964404 |
| 510k Number | K964404 |
| Device Name: | BACFIX SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SPINAL CONCEPTS, INC. 701 BRAZOS SUITE 500 Austin, TX 78701 |
| Contact | Erin Mcgurk |
| Correspondent | Erin Mcgurk SPINAL CONCEPTS, INC. 701 BRAZOS SUITE 500 Austin, TX 78701 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-03-26 |