510(k) K172262

EVOS Small Fragment Plating System by Smith & Nephew, Inc. — Product Code HRS

K172262 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "EVOS Small Fragment Plating System". The FDA issued a decision of Substantially Equivalent on Aug 23, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 23, 2017
Date Received
Jul 27, 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
510(k)