The following data is part of a premarket notification filed by Acromed Corp. with the FDA for M-2 Anterior Plate System.
| Device ID | K972718 |
| 510k Number | K972718 |
| Device Name: | M-2 ANTERIOR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Greg Cannedy |
| Correspondent | Greg Cannedy 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 | 1997-07-21 |
| Decision Date | 1997-10-01 |
| Summary: | summary |