Cleared Traditional

RHS

K060438 · Tornier · Orthopedic
Apr 2006
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K060438 is an FDA 510(k) clearance for the RHS, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on April 18, 2006, 56 days after receiving the submission on February 21, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K060438 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2006
Decision Date April 18, 2006
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDB — Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3160

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