The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Motech Peak Fixation System.
| Device ID | K963350 |
| 510k Number | K963350 |
| Device Name: | DEPUY MOTECH PEAK FIXATION SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-26 |
| Decision Date | 1996-11-14 |
| Summary: | summary |