Cleared Special

K112861 - SINTEA PLUSTEK ANTERIOR CERVICAL PLATE ...

K112861 is an FDA 510(k) clearance for SINTEA PLUSTEK ANTERIOR CERVICAL PLATE ..., manufactured by Sintea Plustek, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 147-day FDA review.

K112861 · Sintea Plustek, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
147d
Days
Class 2
Risk

K112861 is an FDA 510(k) clearance for the SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sintea Plustek, LLC (Miami Beach, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 147 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sintea Plustek, LLC devices

FDA 510(k) Submission Details - K112861

510(k) Number K112861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date February 24, 2012
Days to Decision 147 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

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 491
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K112861.
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
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K112206 · Seaspine, Inc. · Jan 2012
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K113509 · L & K Biomed Co., Ltd. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012