Cleared Traditional

GSO GS1 SPINAL SYSTEM (K070966) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070966 · Gold Standard Orthopaedics, LLC · Orthopedic device
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Jul 2007
Decision
106d
Days
Class 2
Risk

K070966 is an FDA 510(k) clearance for the GSO GS1 SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Gold Standard Orthopaedics, LLC (Louisville, US). The FDA issued a Cleared decision on July 20, 2007 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Gold Standard Orthopaedics, LLC devices

Submission Details

510(k) Number K070966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date July 20, 2007
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 73
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K070966.
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · Globus Medical, Inc. · Jun 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728 · Medtronic Sofamor Danek USA, Inc. · Jan 2009
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K081906 · Globus Medical, Inc. · Nov 2008
SYNTHES PANGEA SYSTEM
K052123 · Synthes (Usa) · Sep 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · Globus Medical, Inc. · Aug 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391 · Globus Medical, Inc. · Jul 2005