Cleared Traditional

K132718 - INTEGRITY SPINE CORE SYSTEM

K132718 is an FDA 510(k) clearance for INTEGRITY SPINE CORE SYSTEM, manufactured by Integrity Spine. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K132718 · Integrity Spine · Orthopedic device
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Nov 2013
Decision
80d
Days
Class 2
Risk

K132718 is an FDA 510(k) clearance for the INTEGRITY SPINE CORE SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Integrity Spine (Austin, US). The FDA issued a Cleared decision on November 18, 2013 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integrity Spine devices

FDA 510(k) Submission Details - K132718

510(k) Number K132718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2013
Decision Date November 18, 2013
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 246
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K132718.
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K131429 · Reliance Medical Systems, LLC · Sep 2013