Cleared Traditional

K143245 - GPC Intramedullary Nailing Systems (FDA 510(k) Clearance)

K143245 · Gpc Medical Limited · Orthopedic device

Sep 2015

Decision

322d

Days

Class 2

Risk

K143245 is an FDA 510(k) clearance for the GPC Intramedullary Nailing Systems. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).

Submitted by Gpc Medical Limited (New Delhi, IN). The FDA issued a Cleared decision on September 30, 2015, 322 days after receiving the submission on November 12, 2014.

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

Submission Details

510(k) Number	K143245 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 12, 2014
Decision Date	September 30, 2015
Days to Decision	322 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF