The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Octafix Occipital Cervical Plating System.
| Device ID | K021009 |
| 510k Number | K021009 |
| Device Name: | OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Contact | David M Hooper |
| Correspondent | David M Hooper SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-28 |
| Decision Date | 2002-06-18 |
| Summary: | summary |