The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Moss Miami Spinal System (anterior Use).
| Device ID | K953915 |
| 510k Number | K953915 |
| Device Name: | MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-21 |
| Decision Date | 1996-02-15 |