Cleared Traditional

K955848 - ORTHOFIX MODULSYSTEM (FDA 510(k) Clearance)

K955848 · Orthofix, Inc. · Orthopedic device

Mar 1996

Decision

84d

Days

Class 2

Risk

K955848 is an FDA 510(k) clearance for the ORTHOFIX MODULSYSTEM. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Orthofix, Inc. (Rockville, US). The FDA issued a Cleared decision on March 20, 1996, 84 days after receiving the submission on December 27, 1995.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K955848 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 27, 1995
Decision Date	March 20, 1996
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF