Cleared Traditional

K083562 - STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM

K083562 is an FDA 510(k) clearance for STRYKER SPINE NULOCK ANTERIOR CERVICAL ..., manufactured by Stryker Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K083562 · Stryker Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
113d
Days
Class 2
Risk

K083562 is an FDA 510(k) clearance for the STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on March 25, 2009 after a review of 113 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 Stryker Corp. devices

FDA 510(k) Submission Details - K083562

510(k) Number K083562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2008
Decision Date March 25, 2009
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 592
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K083562.
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K083020 · Stryker Corp. · Mar 2009
NUVASIVE HELIX-T ACP SYSTEM
K083341 · Nuvasive, Inc. · Mar 2009
PACP
K083663 · Pioneer Surgical Technology · Feb 2009
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K083338 · Seaspine, Inc. · Feb 2009