Cleared Traditional

K905565 - LATERAL BUTTRESS SUPPORT
(FDA 510(k) Clearance)

K905565 · Mcconnell Orthopedic · General & Plastic Surgery

Feb 1991

Decision

71d

Days

Class 1

Risk

K905565 is an FDA 510(k) clearance for the LATERAL BUTTRESS SUPPORT, a Operating Room Accessories Table Tray (Class I — General Controls, product code FWZ), submitted by Mcconnell Orthopedic (Dallas, US). The FDA issued a Cleared decision on February 21, 1991, 71 days after receiving the submission on December 12, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K905565 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 1990
Decision Date	February 21, 1991
Days to Decision	71 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.