Cleared Traditional

K091743 - SEC VBR

K091743 is an FDA 510(k) clearance for SEC VBR, manufactured by Innvotec Surgical, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K091743 · Innvotec Surgical, Inc. · Orthopedic device
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Nov 2009
Decision
139d
Days
Class 2
Risk

K091743 is an FDA 510(k) clearance for the SEC VBR. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Innvotec Surgical, Inc. (Washington, US). The FDA issued a Cleared decision on November 2, 2009 after a review of 139 days - within the typical 510(k) review window.

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.

View all Innvotec Surgical, Inc. devices

FDA 510(k) Submission Details - K091743

510(k) Number K091743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date November 02, 2009
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 211
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K091743.
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · Medtronic Sofamor Danek USA, Inc. · Oct 2010
STAXX XD SYSTEM
K101288 · Spine Wave, Inc. · Sep 2010
AESCULAP HYDROLIFT VBR SYSTEM
K083186 · Aesculap Implant System, Inc. · Mar 2010
C-THRU SPINAL SYSTEM
K092336 · Ebi, L.P. · Oct 2009
ADDPLUS
K090841 · Ulrich GmbH & Co. KG · Oct 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
K091946 · Stryker Spine · Sep 2009