Cleared Traditional

LDR Spine ROI-C Cervical Cage System (K150765) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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 87
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K150765.
Cavetto-SA Cervical Cage System
K173077 · Neurostructures, Inc. · Feb 2018
NuVasive CoRoent Small Interlock II System
K170961 · Nu Vasive, Incorporated · Jun 2017
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K132582 · Exactech, Inc. · Feb 2014
COALITION SPACER
K131449 · Globus Medical, Inc. · Jul 2013