The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Colles C Series Frame Sterile Pack.
| Device ID | K003397 |
| 510k Number | K003397 |
| Device Name: | COLLES C SERIES FRAME STERILE PACK |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE 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 | 2000-11-01 |
| Decision Date | 2001-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868034657 | K003397 | 000 |