Cleared Traditional

K020885 - FASSIRE-DUVAL TELESCOPIC IM SYSTEM (FDA 510(k) Clearance)

K020885 · Pega Medical, Inc. · Orthopedic device

Feb 2003

Decision

325d

Days

Class 2

Risk

K020885 is an FDA 510(k) clearance for the FASSIRE-DUVAL TELESCOPIC IM SYSTEM. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).

Submitted by Pega Medical, Inc. (Quebec, CA). The FDA issued a Cleared decision on February 6, 2003, 325 days after receiving the submission on March 18, 2002.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K020885 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 18, 2002
Decision Date	February 06, 2003
Days to Decision	325 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF