Cleared Traditional

K201905 - SMR 140? Reverse Humeral Body
(FDA 510(k) Clearance)

K201905 · Lima Corporate S.P.A. · Orthopedic

Dec 2020

Decision

161d

Days

Class 2

Risk

K201905 is an FDA 510(k) clearance for the SMR 140? Reverse Humeral Body, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on December 17, 2020, 161 days after receiving the submission on July 9, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K201905 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2020
Decision Date	December 17, 2020
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3670