The following data is part of a premarket notification filed by Apex Tools & Orthopedics Co. with the FDA for Apex Kirschner Wires And Steinmann Pins.
| Device ID | K112254 |
| 510k Number | K112254 |
| Device Name: | APEX KIRSCHNER WIRES AND STEINMANN PINS |
| Classification | Pin, Fixation, Smooth |
| Applicant | APEX TOOLS & ORTHOPEDICS CO. 25 YONGHUA, YONGHE, GETDD Guangzhou, Guangdong, CN Cn-511356 |
| Contact | Scott Liang |
| Correspondent | Scott Liang APEX TOOLS & ORTHOPEDICS CO. 25 YONGHUA, YONGHE, GETDD Guangzhou, Guangdong, CN Cn-511356 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-05 |
| Decision Date | 2011-10-11 |
| Summary: | summary |