The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Acromed Anterior Cervical Stabilization System.
| Device ID | K970462 |
| 510k Number | K970462 |
| Device Name: | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Slly Levine |
| Correspondent | Slly Levine ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-06 |
| Decision Date | 1997-04-03 |
| Summary: | summary |