The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Spinal Concepts, Inc. Ant-cer Dynamic Anterior Cervical Plate System.
| Device ID | K024326 |
| 510k Number | K024326 |
| Device Name: | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINAL CONCEPTS, INC. 5301 RIATA PARK COURT BLDG F Austin, TX 78727 |
| Contact | Lisa Peterson |
| Correspondent | Lisa Peterson SPINAL CONCEPTS, INC. 5301 RIATA PARK COURT BLDG F Austin, TX 78727 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-26 |
| Decision Date | 2003-01-23 |
| Summary: | summary |