The following data is part of a premarket notification filed by Depuy Ace Medical Co. with the FDA for Depuy Ace Timax Pilon Plate.
| Device ID | K982347 |
| 510k Number | K982347 |
| Device Name: | DEPUY ACE TIMAX PILON PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. El Segundo, CA 90245 |
| Contact | Paul Doner |
| Correspondent | Paul Doner 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 | 1998-07-06 |
| Decision Date | 1998-08-31 |
| Summary: | summary |