510(k) K152627

IFS Fixation Scaffold System by Metric Medical Devices, Inc. — Product Code HTY

K152627 is an FDA 510(k) premarket notification submitted by Metric Medical Devices, Inc. for the device "IFS Fixation Scaffold System". The FDA issued a decision of Substantially Equivalent on January 13, 2016. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Metric Medical Devices, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2016
Date Received
September 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type