Cleared Traditional

K122771 - SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

K122771 is an FDA 510(k) clearance for SPINAL ELEMENTS CERVICAL INTERVERTEBRAL..., manufactured by Spinal Elements, Inc.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K122771 · Spinal Elements, Inc. · Orthopedic device
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Jan 2013
Decision
122d
Days
Class 2
Risk

K122771 is an FDA 510(k) clearance for the SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 10, 2013 after a review of 122 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 Spinal Elements, Inc. devices

FDA 510(k) Submission Details - K122771

510(k) Number K122771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2012
Decision Date January 10, 2013
Days to Decision 122 days
Submission Type Traditional
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
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 164
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K122771.
IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
K131951 · X-Spine Systems, Inc. · Aug 2013
COALITION SPACER
K131449 · Globus Medical, Inc. · Jul 2013
INCITE ANCHORED CERVICAL INTERBODY DEVICE
K130306 · Incite Innovation, LLC · Apr 2013
IN:C2 SPINAL FIXATION SYSTEM
K122630 · Spine Smith Partners L.P. · Dec 2012
PRO-LINK CERVICAL SPACER SYSTEM
K121151 · Life Spine, Inc. · Nov 2012
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
K122008 · Incite Innovation, LLC · Nov 2012