Cleared Traditional

MODULAR HIP SYSTEM

K900628 · Richards Medical Co., Inc. · Orthopedic

May 1990

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K900628 is an FDA 510(k) clearance for the MODULAR HIP SYSTEM, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on May 9, 1990, 90 days after receiving the submission on February 8, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K900628 FDA.gov
FDA Decision	Cleared SN
Date Received	February 08, 1990
Decision Date	May 09, 1990
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353