Cleared Traditional

STEINMAN PIN

K960483 · American Medical Specialties, Inc. · Orthopedic

Apr 1996

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K960483 is an FDA 510(k) clearance for the STEINMAN PIN, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by American Medical Specialties, Inc. (Norcross, US). The FDA issued a Cleared decision on April 9, 1996, 67 days after receiving the submission on February 2, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K960483 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1996
Decision Date	April 09, 1996
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement