The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Motech Moss Miami Spinal System.
| Device ID | K982320 |
| 510k Number | K982320 |
| Device Name: | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Lynette Whitaker |
| Correspondent | Lynette Whitaker DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1998-09-14 |
| Summary: | summary |