510(k) K173710

MotoBAND CP Implant System by Crossroads Extremity Systems, LLC — Product Code HWC

K173710 is an FDA 510(k) premarket notification submitted by Crossroads Extremity Systems, LLC for the device "MotoBAND CP Implant System". The FDA issued a decision of Substantially Equivalent on February 12, 2018. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Crossroads Extremity Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2018
Date Received
December 4, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type