The following data is part of a premarket notification filed by Genesis Fracture Care, Inc. with the FDA for G3(tm) Active Plate(r) Small Fragment System.
| Device ID | K160633 |
| 510k Number | K160633 |
| Device Name: | G3(TM) Active Plate(R) Small Fragment 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 MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN Bartlett, TN 38133 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-04-22 |
| Summary: | summary |