Not Cleared Direct

DEN200010 - Spineology Interbody Fusion System

DEN200010 is an FDA 510(k) submission for Spineology Interbody Fusion System, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code OQB cleared through the Direct 510(k) pathway after a 212-day FDA review.

DEN200010 · Spineology, Inc. · Orthopedic device
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Sep 2020
Decision
212d
Days
Class 2
Risk

DEN200010 is an FDA 510(k) submission (not cleared) for the Spineology Interbody Fusion System. Classified as Intervertebral Body Graft Containment Device (product code OQB), Class II - Special Controls.

Submitted by Spineology, Inc. (Saint Paul, US). The FDA issued a Not Cleared (DENG) decision on September 18, 2020 after a review of 212 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3085 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Orthopedic review framework.

FDA 510(k) Submission Details - DEN200010

510(k) Number DEN200010 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 19, 2020
Decision Date September 18, 2020
Days to Decision 212 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 122d · This submission: 212d
Pathway characteristics

OQB Device Classification - Class 2, Special Controls

Product Code OQB Intervertebral Body Graft Containment Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3085
Definition An Intervertebral Body Graft Containment Device Is A Non-rigid, Implanted Spinal Device That Is Designed To Contain Bone Graft Within Its Internal Cavity. The Device Is Inserted Into The Intervertebral Body Space Of The Spine And Is Intended As An Adjunct To Intervertebral Body Fusion.
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.

DEN200010 · Spineology Interbody Fusion System
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