The following data is part of a premarket notification filed by Depuy Ace Medical Co. with the FDA for Depuy Ace Composite Locking Nut.
| Device ID | K983265 |
| 510k Number | K983265 |
| Device Name: | DEPUY ACE COMPOSITE LOCKING NUT |
| Classification | Washer, Bolt Nut |
| Applicant | DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. El Segundo, CA 90245 |
| Contact | Kathleen Dragovich |
| Correspondent | Kathleen Dragovich DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. El Segundo, CA 90245 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1998-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868034084 | K983265 | 000 |
| 00887868033605 | K983265 | 000 |
| 00887868033483 | K983265 | 000 |