The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Motech Anterior Compression Plate System.
Device ID | K962486 |
510k Number | K962486 |
Device Name: | DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
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 | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-26 |
Decision Date | 1996-12-27 |
Summary: | summary |