The following data is part of a premarket notification filed by Depuy Ace Medical Co. with the FDA for Depuy Ace Timax Meta Plate.
| Device ID | K983853 |
| 510k Number | K983853 |
| Device Name: | DEPUY ACE TIMAX META PLATE |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1998-12-22 |
| Summary: | summary |