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 |