Cleared Special

K090751 - COMET ANTERIOR CERVICAL PLATE SYSTEM

K090751 is an FDA 510(k) clearance for COMET ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Apollo Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 217-day FDA review.

K090751 · Apollo Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
217d
Days
Class 2
Risk

K090751 is an FDA 510(k) clearance for the COMET ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Apollo Spine, Inc. (Stoughton, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 217 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K090751

510(k) Number K090751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date October 23, 2009
Days to Decision 217 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
95d slower than avg
Panel avg: 122d · This submission: 217d
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 660
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K090751.
CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K091926 · Choicespine, LP · Dec 2009
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
K092659 · Spinal USA · Nov 2009
XTEND ANTERIOR CERVICAL PLATE SYSTEM
K092146 · Globus Medical, Inc. · Nov 2009
INTERPLATE C
K092070 · Rsb Spine, LLC · Oct 2009
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
K091134 · Custom Spine, Inc. · Aug 2009
TRUSS THORACOLUMBAR PLATE SYSTEM
K092108 · Globus Medical, Inc. · Aug 2009
K090751 · COMET ANTERIOR CERVICAL PLATE SYSTEM
Download PDF FDA Summary Apollo Spine, Inc.