The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Anterior Dynamized System.
| Device ID | K953978 |
| 510k Number | K953978 |
| Device Name: | ANTERIOR DYNAMIZED SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Gregory Cannedy |
| Correspondent | Gregory Cannedy 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 | 1995-08-23 |
| Decision Date | 1997-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034005362 | K953978 | 000 |