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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 116d · 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 Consultant

Tuv Rheinland of North America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K103248.
ITRAC CERVICAL TRACTION SYSTEM
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INTEGRITY SPINAL CARE SYSTEM 3.0
K130249 · Integrity Life Sciences · Feb 2014
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
K112074 · Everyway Medical Instruments Co.,Ltd · Feb 2012
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
K101889 · Pivotal Health Solutions · Aug 2010
MTD 4000
K091540 · Mettler Electronics Corp. · Oct 2009
TM-400
K081247 · Ito Co., Ltd. · Aug 2008

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K103248 · INTEGRITY SPINAL CARE SYSTEM
Download PDF FDA Summary Integra Life Sciences