Skip to content

Savannah Lumbar Percutaneous Stabilization System

by Neurospine Innovations and Solutions

510(k) K072116

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072116 Date20 Mar 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Savannah Lumbar Percutaneous Stabilization System is a percutaneous orthopedic device designed for spinal stabilization. It is classified as a lumbar stabilization system, providing immobilization of lumbar and sacral spinal segments as an adjunct to spinal fusion procedures.

This system is intended for use in surgical settings and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K072116) and falls under the Orthopedic advisory committee category. The device is manufactured by Neurospine Innovations and Solutions, located in Apple Valley, MN.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the Savannah Lumbar Percutaneous Stabilization System intended to support?

    The Savannah Lumbar Percutaneous Stabilization System is designed as an adjunct to spinal fusion procedures, specifically to provide immobilization of lumbar and sacral spinal segments during surgery. It is not intended as a standalone treatment but rather as a supplementary tool to enhance stabilization in those areas.

  • Is the Savannah Lumbar Percutaneous Stabilization System reusable or intended for single-use?

    The Savannah Lumbar Percutaneous Stabilization System is supplied sterile and explicitly intended for single-use only. This ensures patient safety and reduces the risk of infection or cross-contamination between procedures.

  • How is the Savannah Lumbar Percutaneous Stabilization System regulated in the U.S.?

    The Savannah Lumbar Percutaneous Stabilization System is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K072116. It was determined to be substantially equivalent to a predicate device and falls under the Orthopedic advisory committee category (OR). The system was cleared on March 20, 2008.

  • What is the manufacturing location and contact information for the Savannah Lumbar Percutaneous Stabilization System?

    The Savannah Lumbar Percutaneous Stabilization System is manufactured by Neurospine Innovations and Solutions, located at 13540 Guild Ave., Apple Valley, MN 55124. For inquiries, you may contact Richard Jansen, who serves as the point of contact for the manufacturer.