Cleared Special

K122444 - CERVICAL CAGE

K122444 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 Special 510(k) pathway after a 20-day FDA review.

K122444 · Eisertech, LLC · Orthopedic device
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Aug 2012
Decision
20d
Days
Class 2
Risk

K122444 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 August 30, 2012 after a review of 20 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 Eisertech, LLC devices

FDA 510(k) Submission Details - K122444

510(k) Number K122444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2012
Decision Date August 30, 2012
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 K122444.
4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
K121741 · 4-Web, Inc. · Oct 2012
STINGRAY CERVICAL CAGE
K122085 · Omni Surgical, LP Dba Spine360 · Oct 2012
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · Spineart · Oct 2012
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
K121320 · Medyssey Co, Ltd. · Aug 2012
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
K121569 · Accel Spine · Jul 2012