Cleared Traditional

K102322 - STINGRAY CERVICAL CAGE

Also marketed or referenced as:
SHARK IMPLANT (PLIF) BULL SHARK IMPLANT(PLIF) TIGER IMPLANT (TLIF) GREAT WHITE IMPLANTS(ALIF)

K102322 is an FDA 510(k) clearance for STINGRAY CERVICAL CAGE, manufactured by Omni Surgical, L.P.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K102322 · Omni Surgical, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
143d
Days
Class 2
Risk

K102322 is an FDA 510(k) clearance for the STINGRAY CERVICAL CAGE. 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 Omni Surgical, L.P. (Round Rock, US). The FDA issued a Cleared decision on January 7, 2011 after a review of 143 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Omni Surgical, L.P. devices

FDA 510(k) Submission Details - K102322

510(k) Number K102322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date January 07, 2011
Days to Decision 143 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 122d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 687
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K102322.
LANX LATERAL
K103666 · Lanx, Inc. · Mar 2011
PEZO INTERBODY CAGES SYSTEM
K103814 · Ulrich GmbH & Co. KG · Mar 2011
REDONDO-L
K103297 · Seaspine, Inc. · Jan 2011
CALIBER SPACER
K102293 · Globus Medical, Inc. · Jan 2011
PARAMOUNT R IBF DEVICE
K103228 · Theken Spine, LLC · Jan 2011
GENESYS SPINE INTERBODY FUSION SYSTEM
K103034 · Genesys Spine · Dec 2010