510(k) K132244

N-FORCE FIXATION SYSTEM by Innovision, Inc. — Product Code HWC

K132244 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 March 6, 2014. 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
March 6, 2014
Date Received
July 18, 2013
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