The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Modification To Incompass Spinal Fixation System.
| Device ID | K023644 |
| 510k Number | K023644 |
| Device Name: | MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2002-11-25 |
| Summary: | summary |