Cleared Abbreviated

K110915 - CERVICAL CAGE

K110915 is an FDA 510(k) clearance for CERVICAL CAGE, manufactured by Eisertech, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Abbreviated 510(k) pathway after a 112-day FDA review.

K110915 · Eisertech, LLC · Orthopedic device
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Jul 2011
Decision
112d
Days
Class 2
Risk

K110915 is an FDA 510(k) clearance for the CERVICAL CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Eisertech, LLC (San Diego, US). The FDA issued a Cleared decision on July 22, 2011 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Eisertech, LLC devices

FDA 510(k) Submission Details - K110915

510(k) Number K110915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2011
Decision Date July 22, 2011
Days to Decision 112 days
Submission Type Abbreviated
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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Standards-based clearance path.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 312
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K110915.
DAYTONA ANTERIOR CERVICAL CAGE
K110733 · Spinenet, LLC · Aug 2011
PERIMETER C SPINAL SYSTEM
K100967 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
K111675 · Theken Spine, LLC · Aug 2011
PLATEAU SPACER SYSTEM
K111835 · Life Spine, Inc. · Jul 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · Exactech, Inc. · Jun 2011
CAPTIVA SPINE FUSELOX CERVICAL CAGE
K110585 · Captiva Spine, Inc. · Mar 2011