Cleared Traditional

K073232 - INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX

K073232 is an FDA 510(k) clearance for INDUS ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K073232 · Spinefrontier, Inc. · Orthopedic device
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Feb 2008
Decision
97d
Days
Class 2
Risk

K073232 is an FDA 510(k) clearance for the INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on February 20, 2008 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinefrontier, Inc. devices

FDA 510(k) Submission Details - K073232

510(k) Number K073232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2007
Decision Date February 20, 2008
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 555
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K073232.
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
K080815 · Signus Medizintechnik GmbH · Apr 2008
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
K080191 · Depuy Spine, Inc. · Apr 2008
CAYMAN BUTTRESS PLATE SYSTEM
K080302 · K2m, Inc. · Mar 2008
RELIANCE BUTTRESS WASHER SYSTEM
K073349 · Reliance Medical Systems, LLC · Feb 2008
THOR ANTERIOR PLATING SYSTEM
K073437 · Stryker Spine · Feb 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · Nuvasive, Inc. · Jan 2008