The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Ae Tk2 Hip Screw System.
| Device ID | K972629 |
| 510k Number | K972629 |
| Device Name: | DEPUY AE TK2 HIP SCREW SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Kathleen A Dragovich |
| Correspondent | Kathleen A Dragovich DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-10-09 |
| Summary: | summary |