The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Bacfix Spinal Fixation System.
| Device ID | K013887 |
| 510k Number | K013887 |
| Device Name: | BACFIX SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Contact | David M Hopper |
| Correspondent | David M Hopper SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-02-12 |
| Summary: | summary |