The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Spinal Concepts, Inc., Cfix Cable System.
| Device ID | K974020 |
| 510k Number | K974020 |
| Device Name: | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM |
| Classification | Cerclage, 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-22 |
| Decision Date | 1997-12-19 |
| Summary: | summary |