510(k) K151897

MultiFIX® P Knotless Fixation Device by ArthroCare Corporation — Product Code MBI

K151897 is an FDA 510(k) premarket notification submitted by ArthroCare Corporation for the device "MultiFIX® P Knotless Fixation Device". The FDA issued a decision of Substantially Equivalent on August 6, 2015. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. ArthroCare Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2015
Date Received
July 10, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type