510(k) K171372

Alians Elbow Locking Plating System by Newclip Technics — Product Code HRS

K171372 is an FDA 510(k) premarket notification submitted by Newclip Technics for the device "Alians Elbow Locking Plating System". The FDA issued a decision of Substantially Equivalent on January 4, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Newclip Technics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2018
Date Received
May 10, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type