Cleared Special

K093704 - AVS PL PEEK SPACERS

K093704 is an FDA 510(k) clearance for AVS PL PEEK SPACERS, manufactured by Stryker Corp.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 22-day FDA review.

K093704 · Stryker Corp. · Orthopedic device
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Dec 2009
Decision
22d
Days
Class 2
Risk

K093704 is an FDA 510(k) clearance for the AVS PL PEEK SPACERS. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Corp. devices

FDA 510(k) Submission Details - K093704

510(k) Number K093704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2009
Decision Date December 23, 2009
Days to Decision 22 days
Submission Type Special
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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K093704.
VALEO SPACER SYSTEM
K091278 · Amedica Corp. · Jan 2010
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K092162 · Solco Biomedical Co., Ltd. · Jan 2010
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242 · Globus Medical, Inc. · Dec 2009
PERIMETER INTERBODY FUSION DEVICE
K090353 · Medtronic Sofamor Danek · Sep 2009
SPINAL USA INTERBODY CAGES
K092193 · Spinal USA · Sep 2009
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K091638 · Spinefrontier, Inc. · Sep 2009