Cleared Traditional

Conformity stem, cemented

K191056 · United Orthopedic Corporation · Orthopedic
Jan 2020
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K191056 is an FDA 510(k) clearance for the Conformity stem, cemented, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on January 3, 2020, 259 days after receiving the submission on April 19, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K191056 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2019
Decision Date January 03, 2020
Days to Decision 259 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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