Cleared Traditional

K011943 - IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
(FDA 510(k) Clearance)

K011943 · Kensey Nash Corp. · Orthopedic device

Sep 2001

Decision

90d

Days

Class 2

Risk

K011943 is an FDA 510(k) clearance for the IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR. This device is classified as a Cement Obturator (Class II - Special Controls, product code LZN).

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on September 19, 2001, 90 days after receiving the submission on June 21, 2001.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K011943 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 21, 2001
Decision Date	September 19, 2001
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF