Cleared Traditional

K091426 - CERVICORE CORPECTOMY CAGE

K091426 is an FDA 510(k) clearance for CERVICORE CORPECTOMY CAGE, manufactured by Verticor, Ltd.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K091426 · Verticor, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
224d
Days
Class 2
Risk

K091426 is an FDA 510(k) clearance for the CERVICORE CORPECTOMY CAGE. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Verticor, Ltd. (Round Rock, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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.

FDA 510(k) Submission Details - K091426

510(k) Number K091426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date December 23, 2009
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K091426.
ENDURAMESH, MODEL 762.XXX
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SEC VBR
K091743 · Innvotec Surgical, Inc. · Nov 2009
C-THRU SPINAL SYSTEM
K092336 · Ebi, L.P. · Oct 2009
ADDPLUS
K090841 · Ulrich GmbH & Co. KG · Oct 2009
K091426 · CERVICORE CORPECTOMY CAGE
Download PDF FDA Summary Verticor, Ltd.