The following data is part of a premarket notification filed by Genesis Fracture Care, Inc. with the FDA for G3™ Active Plate® Miniature System.
| Device ID | K171293 |
| 510k Number | K171293 |
| Device Name: | G3™ Active Plate® Miniature System |
| Classification | Plate, Fixation, Bone |
| Applicant | Genesis Fracture Care, Inc. 13568 SE 97th Ave., Suite 202 Clackamas, OR 97015 |
| Contact | Michael Bottlang |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Ave Suite 500 Memphis, TN 38119 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-02 |
| Decision Date | 2017-10-23 |
| Summary: | summary |