Cleared Traditional

PARK CITY SHOULDER POSITIONER

K910031 · Orthopedic Systems, Inc. · General & Plastic Surgery

Jan 1991

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K910031 is an FDA 510(k) clearance for the PARK CITY SHOULDER POSITIONER, a Operating Room Accessories Table Tray (Class I — General Controls, product code FWZ), submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on January 24, 1991, 20 days after receiving the submission on January 4, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K910031 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 1991
Decision Date	January 24, 1991
Days to Decision	20 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	FWZ — Operating Room Accessories Table Tray
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4950
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.