Gso GS1 Spinal System

FDA 510(k) K070966 · Gold Standard Orthopaedics, LLC

Substantially Equivalent

510(k) numberK070966

Submission

Device name
Gso GS1 Spinal System
Applicant
Gold Standard Orthopaedics, LLC
Louisville, KY, US
Received
April 5, 2007
Decision date
July 20, 2007
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

Other 510(k)s with product code KWP

510(k)DeviceApplicantDecision
K143278LnK Posterior Cervical Fixation SystemKWP · Traditional L&K BIOMED Co., Ltd.07/29/2015SE
K150753OASYS SystemKWP · Traditional Stryker Corporation06/09/2015SE
K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special Precision Spine, Inc.06/04/2015SE
K142867Reliance Posterior Cervical-Thoracic SystemKWP · Special Reliance Medical Systems, LLC04/29/2015SE
K150254Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional Pioneer Surgical Technology, Inc. (Dba Rti…04/28/2015SE
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

More from K2m

510(k)DeviceDecision
K123487Gso GS1 Cannulated Screw SystemMNH · Traditional 03/11/2013SE
K091359Gso PCT Spinal SystemKWP · Traditional 09/02/2009SE
K063589Gso Bone Fixation FastenersHWC · Traditional 01/31/2007SE

Questions and answers

When was Gso GS1 Spinal System cleared by the FDA?

Gso GS1 Spinal System (K070966) received a 510(k) decision of Substantially Equivalent on July 20, 2007, 106 days after the submission was received.

What is the product code of K070966?

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