The following data is part of a premarket notification filed by Extraortho, Inc. with the FDA for Xtrafix External Fixation System.
| Device ID | K113383 |
| 510k Number | K113383 |
| Device Name: | XTRAFIX EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EXTRAORTHO, INC. 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Marcos Velez-duran |
| Correspondent | Marcos Velez-duran EXTRAORTHO, INC. 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-06-26 |
| Summary: | summary |