Cleared Special

K071372 - MODIFICATION TO: INTERPLATE VBR SYSTEM

K071372 is an FDA 510(k) clearance for MODIFICATION TO: INTERPLATE VBR SYSTEM, manufactured by Rsb Spine, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 26-day FDA review.

K071372 · Rsb Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
26d
Days
Class 2
Risk

K071372 is an FDA 510(k) clearance for the MODIFICATION TO: 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 June 11, 2007 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071372

510(k) Number K071372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2007
Decision Date June 11, 2007
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K071372.
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K071497 · Atlas Spine, Inc. · Jun 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786 · Theken Spine, LLC · Jun 2007
SMALL STATURE SPACERS
K063393 · Biomet Spine · Jun 2007
VISTA -S DEVICE
K070382 · Zimmer Trabecular Metal Technology · May 2007
THEKEN VU MESH VBR SYSTEM
K070381 · Theken Spine, LLC · Apr 2007
XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
K070082 · Vertebration,Inc · Apr 2007
K071372 · MODIFICATION TO: INTERPLATE VBR SYSTEM
Download PDF FDA Summary Rsb Spine, LLC