Cleared Traditional

SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE (K083118) - FDA 510(k) Clearance

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

K083118 · Spinal USA · Orthopedic device
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May 2009
Decision
217d
Days
Class 2
Risk

K083118 is an FDA 510(k) clearance for the SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spinal USA (Pear, US). The FDA issued a Cleared decision on May 27, 2009 after a review of 217 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Spinal USA devices

Submission Details

510(k) Number K083118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2008
Decision Date May 27, 2009
Days to Decision 217 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
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 177
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K083118.
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
PERIMETER C SPINAL SYSTEM
K100967 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · Exactech, Inc. · Jun 2011
PATRIOT SPACERS: COLONIAL ACDF
K072991 · Globus Medical, Inc. · Jan 2008