Cleared Traditional

TEMA Elbow System

K181362 · Lima Corporate S.P.A. · Orthopedic
Feb 2019
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K181362 is an FDA 510(k) clearance for the TEMA Elbow System, a Prosthesis, Elbow, Constrained, Cemented (Class II — Special Controls, product code JDC), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on February 16, 2019, 269 days after receiving the submission on May 23, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3150.

Submission Details

510(k) Number K181362 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2018
Decision Date February 16, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDC — Prosthesis, Elbow, Constrained, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3150

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