Cleared Traditional

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

K213110 · Auxein Medical Private Limited · Orthopedic
Dec 2022
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K213110 is an FDA 510(k) clearance for the AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on December 16, 2022, 448 days after receiving the submission on September 24, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K213110 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2021
Decision Date December 16, 2022
Days to Decision 448 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