Cleared Traditional

CORIN MODULAR MOORE STEM

K881288 · Orthopedic Systems, Inc. · Orthopedic

Jun 1988

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K881288 is an FDA 510(k) clearance for the CORIN MODULAR MOORE STEM, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code LWJ), submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on June 29, 1988, 93 days after receiving the submission on March 28, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number	K881288 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 1988
Decision Date	June 29, 1988
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	LWJ — Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3360