Orthopro, LLC
Round Rock, TX, US
Orthopro, LLC appears in FDA device records in Round Rock, TX. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Orthopro, LLC between 2006 and 2013. The busiest year on record is 2007, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122936 | ANKLE TRAUMA SYSTEM | HRS | Substantially Equivalent | |
| K113006 | I-FUSE HAMMER TOE SYSTEMS | HWC | Substantially Equivalent | |
| K093055 | CSTS SCREW | HWC | Substantially Equivalent | |
| K073228 | DC ULNAR SHORTENING SYSTEM | HRS | Substantially Equivalent | |
| K070555 | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES | HTY | Substantially Equivalent | |
| K071243 | METAL HEMI IMPLANT | KWD | Substantially Equivalent | |
| K062908 | ORTHROPRO HEMI TOE | KWD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2228-2008 | 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 arthroplasty. | Labeling presented conflicting information as to whether device was sterile or not. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain