Cleared Traditional

K103248 - INTEGRITY SPINAL CARE SYSTEM

K103248 is an FDA 510(k) clearance for INTEGRITY SPINAL CARE SYSTEM, manufactured by Integra Life Sciences. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K103248 · Integra Life Sciences · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
153d
Days
Class 2
Risk

K103248 is an FDA 510(k) clearance for the INTEGRITY SPINAL CARE SYSTEM. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Integra Life Sciences (Las Vegas, US). The FDA issued a Cleared decision on April 5, 2011 after a review of 153 days - an extended review cycle.

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. Standard predicate reliance. 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.

View all Integra Life Sciences devices

FDA 510(k) Submission Details - K103248

510(k) Number K103248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2010
Decision Date April 05, 2011
Days to Decision 153 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 12
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