Cleared Special

IDEAL Ziploop

K233552 · Riverpoint Medical · Orthopedic
Nov 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K233552 is an FDA 510(k) clearance for the IDEAL Ziploop, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on November 30, 2023, 27 days after receiving the submission on November 3, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K233552 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2023
Decision Date November 30, 2023
Days to Decision 27 days
Submission Type Special
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