The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Xtrafix External Fixation System, Xtrafix Small External Fixation System.
| Device ID | K141697 |
| 510k Number | K141697 |
| Device Name: | XTRAFIX EXTERNAL FIXATION SYSTEM, 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 |
| Contact | Romil Sheth |
| Correspondent | Romil Sheth 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 | 2014-06-24 |
| Decision Date | 2014-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024080577 | K141697 | 000 |
| 00889024080591 | K141697 | 000 |
| 00889024080607 | K141697 | 000 |
| 00889024080614 | K141697 | 000 |
| 00889024080621 | K141697 | 000 |
| 00889024080928 | K141697 | 000 |
| 00889024081130 | K141697 | 000 |
| 00889024080331 | K141697 | 000 |
| 00889024080409 | K141697 | 000 |
| 00889024080584 | K141697 | 000 |