The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Modification To: Sterile Colles Classic Fixator.
| Device ID | K013503 |
| 510k Number | K013503 |
| Device Name: | MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2001-11-16 |
| Summary: | summary |