The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Spinal Concepts, Inc. Insight Pedicle Screw System.
| Device ID | K031855 |
| 510k Number | K031855 |
| Device Name: | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | Lisa Peterson |
| Correspondent | Lisa Peterson SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-09-17 |
| Summary: | summary |