Cleared Traditional

MITEK THREADED ANCHOR (FASTIN)

K953560 · Mitek Surgical Products, Inc. · Orthopedic

Jan 1996

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K953560 is an FDA 510(k) clearance for the MITEK THREADED ANCHOR (FASTIN), a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Mitek Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on January 31, 1996, 195 days after receiving the submission on July 20, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K953560 FDA.gov
FDA Decision	Cleared SN
Date Received	July 20, 1995
Decision Date	January 31, 1996
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—