The following data is part of a premarket notification filed by Evergreen Orthopedic Research Lab with the FDA for Kirschner Wires, Steinman Pins.
| Device ID | K102215 |
| 510k Number | K102215 |
| Device Name: | KIRSCHNER WIRES, STEINMAN PINS |
| Classification | Pin, Fixation, Smooth |
| Applicant | EVERGREEN ORTHOPEDIC RESEARCH LAB 11321 NE 120TH ST Kirkland, WA 98034 |
| Contact | Wayne Morse |
| Correspondent | Wayne Morse EVERGREEN ORTHOPEDIC RESEARCH LAB 11321 NE 120TH ST Kirkland, WA 98034 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-06 |
| Decision Date | 2010-11-09 |
| Summary: | summary |