Cleared Traditional

C FIT CUP

K903938 · Orthopedic Systems, Inc. · Orthopedic
Jan 1991
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K903938 is an FDA 510(k) clearance for the C FIT CUP, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Orthopedic Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 4, 1991, 130 days after receiving the submission on August 27, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K903938 FDA.gov
FDA Decision Cleared SN
Date Received August 27, 1990
Decision Date January 04, 1991
Days to Decision 130 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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