The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Motech Profile Anterior Thoracolumbar Plate System.
| Device ID | K973060 |
| 510k Number | K973060 |
| Device Name: | DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | John D Van Vleet |
| Correspondent | John D Van Vleet DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-11-03 |
| Summary: | summary |