The following data is part of a premarket notification filed by Depuy Ace Medical Co. with the FDA for Modification Of Depuy Ace Timax Medial Pilon Plate.
| Device ID | K990120 |
| 510k Number | K990120 |
| Device Name: | MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-13 |
| Decision Date | 1999-02-01 |
| Summary: | summary |