Cleared Traditional

K150765 - LDR Spine ROI-C Cervical Cage System

K150765 is an FDA 510(k) clearance for LDR Spine ROI-C Cervical Cage System, manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K150765 · Ldr Spine USA · Orthopedic device
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Sep 2015
Decision
177d
Days
Class 2
Risk

K150765 is an FDA 510(k) clearance for the LDR Spine ROI-C Cervical Cage System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on September 17, 2015 after a review of 177 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 Ldr Spine USA devices

FDA 510(k) Submission Details - K150765

510(k) Number K150765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2015
Decision Date September 17, 2015
Days to Decision 177 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 122d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 124
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K150765.
Cervical Stand Alone System
K161280 · Orthofix, Inc. · Jun 2016
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
ROI-C Titanium-Coated Implant System
K151934 · Ldr Spine USA · Dec 2015
A-CIFT SoloFuse
K151198 · Spinefrontier, Inc. · Jul 2015
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · Spineart · Feb 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · Medtronic Sofamor Danek USA, Inc. · Jan 2015