Cleared Traditional

Delta Multihole TT Pro Acetabular System

K200656 · Lima Corporate S.P.A. · Orthopedic

Jul 2020

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K200656 is an FDA 510(k) clearance for the Delta Multihole TT Pro Acetabular System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on July 8, 2020, 118 days after receiving the submission on March 12, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K200656 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2020
Decision Date	July 08, 2020
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358