Cleared Traditional

K061401 - INTERPLATE VBR SYSTEM

K061401 is an FDA 510(k) clearance for INTERPLATE VBR SYSTEM, manufactured by Rsb Spine, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K061401 · Rsb Spine, LLC · Orthopedic device
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Aug 2006
Decision
91d
Days
Class 2
Risk

K061401 is an FDA 510(k) clearance for the INTERPLATE VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Rsb Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on August 18, 2006 after a review of 91 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 Rsb Spine, LLC devices

FDA 510(k) Submission Details - K061401

510(k) Number K061401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2006
Decision Date August 18, 2006
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 K061401.
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · Ebi, L.P. · Oct 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
VERTE-STACK SPINAL SYSTEM
K062427 · Medtronic Sofamor Danek · Sep 2006
SYNEX II
K061891 · Synthes Spine Co.Lp · Aug 2006
AVS PL PEEK SPACER SYSTEM
K062132 · Stryker Spine · Aug 2006
SPINAL USA VBR SYSTEM
K061752 · Spinal USA · Aug 2006