The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Spinal Concepts, Inc. (sci) Anterior Cervical Plate System.
| Device ID | K990005 |
| 510k Number | K990005 |
| Device Name: | SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINAL CONCEPTS, INC. 820O CAMERON RD., SUITE B-160 Austin, TX 78754 |
| Contact | Pepper A Chastain |
| Correspondent | Pepper A Chastain SPINAL CONCEPTS, INC. 820O CAMERON RD., SUITE B-160 Austin, TX 78754 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-04 |
| Decision Date | 1999-02-12 |
| Summary: | summary |