The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Orthotech Spiked Washer.
Device ID | K983906 |
510k Number | K983906 |
Device Name: | DEPUY ORTHOTECH SPIKED WASHER |
Classification | Washer, Bolt Nut |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Sally Foust |
Correspondent | Sally Foust DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | HTN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-03 |
Decision Date | 1998-12-18 |
Summary: | summary |