Cleared Traditional

OsteoFab Suture Anchors

K190915 · Oxford Performance Materials, Inc. · Orthopedic
Jul 2019
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K190915 is an FDA 510(k) clearance for the OsteoFab Suture Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Oxford Performance Materials, Inc. (South Windsor, US). The FDA issued a Cleared decision on July 3, 2019, 85 days after receiving the submission on April 9, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K190915 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2019
Decision Date July 03, 2019
Days to Decision 85 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