Cleared Traditional

STRETTO? Cable System

K231333 · Globus Medical, Inc. · Orthopedic
Aug 2023
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K231333 is an FDA 510(k) clearance for the STRETTO? Cable System, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on August 4, 2023, 88 days after receiving the submission on May 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K231333 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2023
Decision Date August 04, 2023
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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