Cleared Traditional

K051013 - SPINEMED S200B/S200C

K051013 is an FDA 510(k) clearance for SPINEMED S200B/S200C, manufactured by Cert Health Sciences, LLC. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K051013 · Cert Health Sciences, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
6d
Days
Class 2
Risk

K051013 is an FDA 510(k) clearance for the SPINEMED S200B/S200C. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Cert Health Sciences, LLC (Columbia, US). The FDA issued a Cleared decision on April 27, 2005 after a review of 6 days - a notably fast clearance 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: 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 Cert Health Sciences, LLC devices

FDA 510(k) Submission Details - K051013

510(k) Number K051013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2005
Decision Date April 27, 2005
Days to Decision 6 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
110d faster than avg
Panel avg: 116d · This submission: 6d
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.
TAMAS BORSAI

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 47
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K051013.
TRACTION SYSTEM, DIGIT-TRAC 930
K052453 · Ever Prosperous Instrument, Inc. · Jan 2006
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
K053503 · Vax-D Medical Technologies USA, L.C. · Dec 2005
TRITON/TRU-TRAC/TX TRACTION DEVICES
K051938 · Chattanooga Group · Sep 2005
BASS ANTALGIC-TRAK
K042482 · Traction Masters, LLC · Mar 2005
HEALTHSTAR ELITE
K043239 · Hill Laboratories Co. · Dec 2004
EXTENTRAC ELITE
K031996 · Advanced Back Technologies · Jul 2004

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.