The following data is part of a premarket notification filed by Acromed Corp. with the FDA for University Plate Anterior System.
| Device ID | K980228 |
| 510k Number | K980228 |
| Device Name: | UNIVERSITY PLATE ANTERIOR SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | William Christianson |
| Correspondent | William Christianson ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-22 |
| Decision Date | 1998-04-14 |
| Summary: | summary |