The following data is part of a premarket notification filed by Genesis Fracture Care, Inc. with the FDA for G3¿ Active Plate® Large Fragment System.
Device ID | K152242 |
510k Number | K152242 |
Device Name: | G3¿ Active Plate® Large Fragment System |
Classification | Plate, Fixation, Bone |
Applicant | GENESIS FRACTURE CARE, INC. 13568 SE 97TH AVE., SUITE 202 Clackamas, OR 97105 |
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 | 2015-08-10 |
Decision Date | 2015-11-24 |
Summary: | summary |