Cleared Traditional

K092070 - INTERPLATE C

K092070 is an FDA 510(k) clearance for INTERPLATE C, manufactured by Rsb Spine, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K092070 · Rsb Spine, LLC · Orthopedic device
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Oct 2009
Decision
90d
Days
Class 2
Risk

K092070 is an FDA 510(k) clearance for the INTERPLATE C. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Rsb Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on October 6, 2009 after a review of 90 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 Rsb Spine, LLC devices

FDA 510(k) Submission Details - K092070

510(k) Number K092070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2009
Decision Date October 06, 2009
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 509
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K092070.
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TRUSS THORACOLUMBAR PLATE SYSTEM
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K091159 · Synthes Spine · Jul 2009
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
K091044 · Spinal USA · Jul 2009