Cleared Abbreviated

K122085 - STINGRAY CERVICAL CAGE

K122085 is an FDA 510(k) clearance for STINGRAY CERVICAL CAGE, manufactured by Omni Surgical, LP Dba Spine360. The device is a Class 2 Orthopedic device with product code ODP cleared through the Abbreviated 510(k) pathway after a 93-day FDA review.

K122085 · Omni Surgical, LP Dba Spine360 · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
93d
Days
Class 2
Risk

K122085 is an FDA 510(k) clearance for the STINGRAY CERVICAL CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Omni Surgical, LP Dba Spine360 (Austin, US). The FDA issued a Cleared decision on October 17, 2012 after a review of 93 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 Omni Surgical, LP Dba Spine360 devices

FDA 510(k) Submission Details - K122085

510(k) Number K122085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date October 17, 2012
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 K122085.
K7C SPACER
K123388 · K7, LLC · Jan 2013
CONSTRUX MINI PEEK TI SPACER SYSTEM
K121649 · Orthofix · Nov 2012
4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
K121741 · 4-Web, Inc. · Oct 2012
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · Spineart · Oct 2012
CERVICAL CAGE
K122444 · Eisertech, LLC · Aug 2012
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012