The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for K-centrum Anterior Spinal Fixation System.
| Device ID | K002371 |
| 510k Number | K002371 |
| Device Name: | K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINEOLOGY, INC. 1815 NORTHWESTERN AVE. Stillwater, MN 55082 |
| Contact | Pamela Snyder |
| Correspondent | Pamela Snyder SPINEOLOGY, INC. 1815 NORTHWESTERN AVE. Stillwater, MN 55082 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-27 |
| Decision Date | 2000-09-15 |