Cleared Traditional

K103248 - INTEGRITY SPINAL CARE SYSTEM (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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 70
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