The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Tempfix External Fixation System, Mr Safe.
| Device ID | K043113 |
| 510k Number | K043113 |
| Device Name: | TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Claudia S Swanson |
| Correspondent | Claudia S Swanson DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-10 |
| Decision Date | 2005-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868034640 | K043113 | 000 |
| 00887868034633 | K043113 | 000 |
| 00887868034565 | K043113 | 000 |