Cleared Traditional

K130948 - C-FUSE CERVICAL INTERVERTEBRAL BODY FUS...

K130948 is an FDA 510(k) clearance for C-FUSE CERVICAL INTERVERTEBRAL BODY FUS..., manufactured by Southern Spine, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K130948 · Southern Spine, LLC · Orthopedic device
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Aug 2013
Decision
131d
Days
Class 2
Risk

K130948 is an FDA 510(k) clearance for the C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Southern Spine, LLC (Alpharetta, US). The FDA issued a Cleared decision on August 14, 2013 after a review of 131 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 Southern Spine, LLC devices

FDA 510(k) Submission Details - K130948

510(k) Number K130948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2013
Decision Date August 14, 2013
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 246
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K130948.
TYBER MEDICAL INTERBODY SYSTEM
K130573 · Tyber Medical, LLC · Sep 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
RELIANCE CERVICAL IBF SYSTEM
K131429 · Reliance Medical Systems, LLC · Sep 2013
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · Spineart · Oct 2012
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012