The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Ace Calcaneal Peri-articular Plate.
| Device ID | K993465 |
| 510k Number | K993465 |
| Device Name: | DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Arlene C Saull |
| Correspondent | Arlene C Saull DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-13 |
| Decision Date | 2000-01-11 |
| Summary: | summary |