Gso PCT Spinal System

FDA 510(k) K091359 · Gold Standard Orthopaedics, LLC

Substantially Equivalent

510(k) numberK091359

Submission

Device name
Gso PCT Spinal System
Applicant
Gold Standard Orthopaedics, LLC
Louisville, KY, US
Received
May 8, 2009
Decision date
September 2, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWP – Appliance, Fixation, Spinal Interlaminal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3050
Specialty
Orthopedic
Implant
Yes

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K142253SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/23/2015SE
K150229SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/07/2015SE
K143249SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/07/2015SE
K142741OASYS SystemKWP · Traditional Stryker Corporation01/15/2015SE
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special K2m12/22/2014SE

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K123487Gso GS1 Cannulated Screw SystemMNH · Traditional 03/11/2013SE
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Questions and answers

When was Gso PCT Spinal System cleared by the FDA?

Gso PCT Spinal System (K091359) received a 510(k) decision of Substantially Equivalent on September 2, 2009, 117 days after the submission was received.

What is the product code of K091359?

The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.