The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Modification To Spinal Concepts Bacfix Spinal Fixation System.
| Device ID | K983258 |
| 510k Number | K983258 |
| Device Name: | MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINAL CONCEPTS, INC. 820O CAMERON RD., SUITE B-160 Austin, TX 78754 |
| Contact | Teena M Augostino |
| Correspondent | Teena M Augostino SPINAL CONCEPTS, INC. 820O CAMERON RD., SUITE B-160 Austin, TX 78754 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-16 |
| Decision Date | 1998-10-21 |
| Summary: | summary |