Cleared Traditional

SPECTRON EF ACETABULAR COMPONENT

K874619 · Richards Medical Co., Inc. · Orthopedic
Feb 1988
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K874619 is an FDA 510(k) clearance for the SPECTRON EF ACETABULAR COMPONENT, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on February 17, 1988, 100 days after receiving the submission on November 9, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K874619 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1987
Decision Date February 17, 1988
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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