510(k) K150166

Extremity Medical Suture Anchor by Extremity Medical, LLC — Product Code MBI

K150166 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "Extremity Medical Suture Anchor". The FDA issued a decision of Substantially Equivalent on February 23, 2015. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2015
Date Received
January 26, 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