Cleared Traditional

K120603 - VARILIFT -C

K120603 is an FDA 510(k) clearance for VARILIFT -C, manufactured by Wenzel Spine. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K120603 · Wenzel Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
336d
Days
Class 2
Risk

K120603 is an FDA 510(k) clearance for the VARILIFT -C. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Wenzel Spine (Austin, US). The FDA issued a Cleared decision on January 29, 2013 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K120603

510(k) Number K120603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date January 29, 2013
Days to Decision 336 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
214d slower than avg
Panel avg: 122d · This submission: 336d
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 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K120603.
INTERVERTEBRAL BODY FUSION DEVICE
K122872 · Dio Medical Co., Ltd. · Feb 2013
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
K122518 · Bm Korea Co., Ltd. · Feb 2013
MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
K123206 · Maxim Surgical · Feb 2013
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