510(k) K151146

N-Force Fixation System by Innovision, Inc. — Product Code HWC

K151146 is an FDA 510(k) premarket notification submitted by Innovision, Inc. for the device "N-Force Fixation System". The FDA issued a decision of Substantially Equivalent on July 24, 2015. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Innovision, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2015
Date Received
April 29, 2015
Clearance Type
Traditional
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