The following data is part of a premarket notification filed by Evergreen Orthopedic Research Lab with the FDA for Iknee Distal Femoral Cutting Guide.
| Device ID | K140689 |
| 510k Number | K140689 |
| Device Name: | IKNEE DISTAL FEMORAL CUTTING GUIDE |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | EVERGREEN ORTHOPEDIC RESEARCH LAB 11321 NE 120TH ST Kirkland, WA 98034 |
| Contact | Jeff Stepanian |
| Correspondent | Jeff Stepanian EVERGREEN ORTHOPEDIC RESEARCH LAB 11321 NE 120TH ST Kirkland, WA 98034 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-19 |
| Decision Date | 2014-08-22 |
| Summary: | summary |