Cleared Traditional

TEMA Elbow system - Line extension

K222807 · Lima Corporate S.P.A. · Orthopedic
Oct 2022
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K222807 is an FDA 510(k) clearance for the TEMA Elbow system - Line extension, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on October 26, 2022, 40 days after receiving the submission on September 16, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K222807 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2022
Decision Date October 26, 2022
Days to Decision 40 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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