The following data is part of a premarket notification filed by Depuy Motech with the FDA for Depuy Motech Moss Miami Spinal System - Pedicle Fixation.
| Device ID | K950697 |
| 510k Number | K950697 |
| Device Name: | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DEPUY MOTECH P.O. BOX 988 700 ORTHOPEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Sally Foust |
| Correspondent | Sally Foust DEPUY MOTECH P.O. BOX 988 700 ORTHOPEDIC DRIVE 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 | 1995-02-06 |
| Decision Date | 1995-06-22 |