Cleared Traditional

K132029 - VAULT-C INTERVERTEBRAL BODY FUSION DEVICE

K132029 is an FDA 510(k) clearance for VAULT-C INTERVERTEBRAL BODY FUSION DEVICE, manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K132029 · Spinal USA · Orthopedic device
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Nov 2013
Decision
147d
Days
Class 2
Risk

K132029 is an FDA 510(k) clearance for the VAULT-C INTERVERTEBRAL BODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spinal USA (Colorado Springs, US). The FDA issued a Cleared decision on November 25, 2013 after a review of 147 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 USA devices

FDA 510(k) Submission Details - K132029

510(k) Number K132029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date November 25, 2013
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 124
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K132029.
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K132582 · Exactech, Inc. · Feb 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K132894 · Zimmer Spine, Inc. · Jan 2014
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
K131880 · Spinefrontier, Inc. · Jan 2014
IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
K131951 · X-Spine Systems, Inc. · Aug 2013
COALITION SPACER
K131449 · Globus Medical, Inc. · Jul 2013
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K122771 · Spinal Elements, Inc. · Jan 2013