Cleared Traditional

K910274 - ARTIFLEX(TM)
(FDA 510(k) Clearance)

K910274 · Beiersdorf, Inc. · Orthopedic device

Mar 1991

Decision

41d

Days

Class 1

Risk

K910274 is an FDA 510(k) clearance for the ARTIFLEX(TM). This device is classified as a Component, Cast (Class I - General Controls, product code LGF).

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on March 5, 1991, 41 days after receiving the submission on January 23, 1991.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.5940.

Submission Details

510(k) Number	K910274 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 23, 1991
Decision Date	March 05, 1991
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—