Cleared Traditional

Integrity? Bone Staple Fixation System

K223860 · Anika Therapeutics, Inc. · Orthopedic
May 2023
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K223860 is an FDA 510(k) clearance for the Integrity? Bone Staple Fixation System, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on May 22, 2023, 150 days after receiving the submission on December 23, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K223860 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2022
Decision Date May 22, 2023
Days to Decision 150 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040