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 | K980447 |
| 510k Number | K980447 |
| Device Name: | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE 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 | 1998-02-05 |
| Decision Date | 1998-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034023601 | K980447 | 000 |
| 10705034023595 | K980447 | 000 |