Cleared Traditional

K111796 - INVIZIA ANTERIOR CERVICAL PLATE SYSTEM

K111796 is an FDA 510(k) clearance for INVIZIA ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Zimmer Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K111796 · Zimmer Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
122d
Days
Class 2
Risk

K111796 is an FDA 510(k) clearance for the INVIZIA ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Zimmer Spine, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 122 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 Zimmer Spine, Inc. devices

FDA 510(k) Submission Details - K111796

510(k) Number K111796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date October 27, 2011
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 602
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K111796.
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
K111132 · Genesys Spine · Dec 2011
ZAVATION CERVICAL PLATE SYSTEM
K112533 · Zavation, LLC · Dec 2011
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · Medos International SARL · Nov 2011
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K111528 · Pioneer Surgical Technology, Inc. · Aug 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · K2m, Inc. · Aug 2011
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
K110990 · Gold Standard Orthopedics, LLC · Jul 2011