Cleared Traditional

K140066 - INFILL CERVICAL

K140066 is an FDA 510(k) clearance for INFILL CERVICAL, manufactured by Pinnacle Spine Group, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K140066 · Pinnacle Spine Group, LLC · Orthopedic device
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May 2014
Decision
115d
Days
Class 2
Risk

K140066 is an FDA 510(k) clearance for the INFILL CERVICAL. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Pinnacle Spine Group, LLC (Dallas, US). The FDA issued a Cleared decision on May 5, 2014 after a review of 115 days - within the typical 510(k) review window.

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 Pinnacle Spine Group, LLC devices

FDA 510(k) Submission Details - K140066

510(k) Number K140066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2014
Decision Date May 05, 2014
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 250
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K140066.
EXACTECH CERVICAL SPACER SYSTEM
K141129 · Exactech, Inc. · Aug 2014
COROENT SMALL INTERBODY SYSTEM
K140921 · Nu Vasive, Incorporated · Jul 2014
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
K132732 · Medyssey USA, Inc. · Jul 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
COROENT SMALL INTERBODY SYSTEM
K140003 · Nuvasive, Inc. · Apr 2014
C-BOX PEEK CERVICAL IBF
K132991 · Innovasis, Inc. · Feb 2014