Cleared Traditional

K130249 - INTEGRITY SPINAL CARE SYSTEM 3.0

K130249 is an FDA 510(k) clearance for INTEGRITY SPINAL CARE SYSTEM 3.0, manufactured by Integrity Life Sciences. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K130249 · Integrity Life Sciences · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
370d
Days
Class 2
Risk

K130249 is an FDA 510(k) clearance for the INTEGRITY SPINAL CARE SYSTEM 3.0. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Integrity Life Sciences (Tampa, US). The FDA issued a Cleared decision on February 6, 2014 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - the FDA physical medicine device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130249

510(k) Number K130249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2013
Decision Date February 06, 2014
Days to Decision 370 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 116d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ITH Equipment, Traction, Powered

All 58
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K130249.
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K130249 · INTEGRITY SPINAL CARE SYSTEM 3.0
Download PDF FDA Summary Integrity Life Scienc…