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 | K972568 |
| 510k Number | K972568 |
| Device Name: | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Vickie E Arford |
| Correspondent | Vickie E Arford DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034020341 | K972568 | 000 |
| 10705034020334 | K972568 | 000 |
| 10705034020327 | K972568 | 000 |
| 10705034020310 | K972568 | 000 |
| 10705034019741 | K972568 | 000 |