Company ยท US
Orthopro, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2013. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2013 | K122936 | ANKLE TRAUMA SYSTEM Orthopro, LLC | HRS |
| May 25, 2012 | K113006 | I-FUSE HAMMER TOE SYSTEMS Orthopro, LLC | HWC |
| Nov 22, 2010 | K093055 | CSTS SCREW Orthopro, LLC | HWC |
| Feb 29, 2008 | K073228 | DC ULNAR SHORTENING SYSTEM Orthopro, LLC | HRS |
| Jul 13, 2007 | K070555 | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES Orthopro, LLC | HTY |
| May 23, 2007 | K071243 | METAL HEMI IMPLANT Orthopro, LLC | KWD |
| Nov 13, 2006 | K062908 | ORTHROPRO HEMI TOE Orthopro, LLC | KWD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | OrthoPro LLC Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplas Terminated |
KWD | K071243 |