Gso GS1 Cannulated Screw System

FDA 510(k) K123487 · Gold Standard Orthopaedics, LLC

Substantially Equivalent

510(k) numberK123487

Submission

Device name
Gso GS1 Cannulated Screw System
Applicant
Gold Standard Orthopaedics, LLC
Louisville, KY, US
Received
November 13, 2012
Decision date
March 11, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Gso GS1 Cannulated Screw System cleared by the FDA?

Gso GS1 Cannulated Screw System (K123487) received a 510(k) decision of Substantially Equivalent on March 11, 2013, 118 days after the submission was received.

What is the product code of K123487?

The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.