The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Xtrafix Small External Fixation System.
| Device ID | K131413 |
| 510k Number | K131413 |
| Device Name: | XTRAFIX SMALL EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-16 |
| Decision Date | 2014-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024080324 | K131413 | 000 |
| 00889024080775 | K131413 | 000 |
| 00889024080799 | K131413 | 000 |
| 00889024080805 | K131413 | 000 |
| 00889024080829 | K131413 | 000 |
| 00889024080843 | K131413 | 000 |
| 00889024081420 | K131413 | 000 |
| 00889024081437 | K131413 | 000 |
| 00889024081444 | K131413 | 000 |
| 00889024081451 | K131413 | 000 |
| 00889024081468 | K131413 | 000 |
| 00889024081475 | K131413 | 000 |
| 00889024080294 | K131413 | 000 |
| 00889024080300 | K131413 | 000 |
| 00889024080317 | K131413 | 000 |
| 00889024080768 | K131413 | 000 |