The following data is part of a premarket notification filed by Orthopro Llc with the FDA for Ankle Trauma System.
| Device ID | K122936 |
| 510k Number | K122936 |
| Device Name: | ANKLE TRAUMA SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPRO LLC 3939 Wasatch Blvd Ste 19 Salt Lake City, UT 84124 |
| Contact | Brock Johnson |
| Correspondent | Brock Johnson ORTHOPRO LLC 3939 Wasatch Blvd Ste 19 Salt Lake City, UT 84124 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2013-02-28 |
| Summary: | summary |