The following data is part of a premarket notification filed by Arex Usa Llc with the FDA for X-fix Dynamic External Distractor.
| Device ID | K122415 |
| 510k Number | K122415 |
| Device Name: | X-FIX DYNAMIC EXTERNAL DISTRACTOR |
| Classification | Pin, Fixation, Smooth |
| Applicant | AREX USA LLC 1709 HILL ST. Edgewater, FL 32132 |
| Contact | Charles Hokanson |
| Correspondent | Charles Hokanson AREX USA LLC 1709 HILL ST. Edgewater, FL 32132 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-08 |
| Decision Date | 2013-03-15 |
| Summary: | summary |