The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Motech Moss Miami Spinal System.
| Device ID | K982011 |
| 510k Number | K982011 |
| Device Name: | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 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 | 1998-06-08 |
| Decision Date | 1998-08-06 |
| Summary: | summary |