The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Acromed Moss Spinal System.
| Device ID | K984378 |
| 510k Number | K984378 |
| Device Name: | DEPUY ACROMED MOSS SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | MNI |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1998-12-30 |
| Summary: | summary |