Cleared Traditional

K150655 - OIC Intramedullary Nail System (FDA 510(k) Clearance)

K150655 · Orthopaedic Implant Company · Orthopedic device

Jul 2015

Decision

118d

Days

Class 2

Risk

K150655 is an FDA 510(k) clearance for the OIC Intramedullary Nail System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).

Submitted by Orthopaedic Implant Company (Reno, US). The FDA issued a Cleared decision on July 9, 2015, 118 days after receiving the submission on March 13, 2015.

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

Submission Details

510(k) Number	K150655 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 13, 2015
Decision Date	July 09, 2015
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF