Orthopro, LLC
Medical device manufacturer in Salt Lake City, UT.
7510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K122936 | Ankle Trauma SystemHRS · Traditional | 02/28/2013SE |
| K113006 | I-Fuse Hammer Toe SystemsHWC · Traditional | 05/25/2012SE |
| K093055 | CSTS ScrewHWC · Traditional | 11/22/2010SE |
| K073228 | DC Ulnar Shortening SystemHRS · Traditional | 02/29/2008SE |
| K070555 | Orthopro Steinman Pins and Kirschner WiresHTY · Traditional | 07/13/2007SE |
| K071243 | Metal Hemi ImplantKWD · Special | 05/23/2007SE |
| K062908 | Orthropro Hemi ToeKWD · Traditional | 11/13/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2228-2008 | Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03…Labeling presented conflicting information as to whether device was sterile or not. | 05/29/2008Terminated |