The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Tempfix External Fixation System.
| Device ID | K021933 |
| 510k Number | K021933 |
| Device Name: | TEMPFIX EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Cheryl K Hastings |
| Correspondent | Cheryl K Hastings 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 | 2002-06-12 |
| Decision Date | 2002-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868047763 | K021933 | 000 |
| 00887868047756 | K021933 | 000 |
| 00887868047749 | K021933 | 000 |
| 00887868047732 | K021933 | 000 |
| 00887868047725 | K021933 | 000 |
| 00887868034626 | K021933 | 000 |
| 00887868034619 | K021933 | 000 |
| 00887868034572 | K021933 | 000 |