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Stowe Pedicle Screw System

by Black Box Medical

510(k) K181554

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 · Special NumberK181554 Date27 Jul 2018ClearedStatusActive

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  • Withdrawn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 Stowe Pedicle Screw System is a spinal fixation device classified as a pedicle screw system under product code NKB. It provides mechanical stabilization and immobilization of spinal segments, designed to address thoracic, lumbar, and sacral instabilities as an adjunct to spinal fusion procedures. The system includes polyaxial screws, longitudinal rods, and transverse connectors to facilitate secure fixation.

This system is intended for surgical implantation by orthopedic or spinal surgeons in clinical settings. It is supplied as a sterile, single-use device and has received FDA 510(k) clearance under Special Review via the Orthopedic (OR) Advisory Committee. Components are engineered for compatibility with standard spinal surgical techniques and are regulated under the Substantially Equivalent (SESE) classification (K181554)

Other devices from Black Box Medical

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 spinal instabilities is the Stowe Pedicle Screw System designed to address, and how does it achieve stabilization?

    The Stowe Pedicle Screw System is specifically designed to address instabilities in the thoracic, lumbar, and sacral regions of the spine. It achieves mechanical stabilization and immobilization through a combination of polyaxial screws, longitudinal rods, and transverse connectors. These components work together to secure spinal segments, providing rigid fixation as an adjunct to spinal fusion procedures.

  • Is the Stowe Pedicle Screw System intended for reuse, or is it meant to be used only once per patient?

    The Stowe Pedicle Screw System is supplied as a sterile, single-use device. This means each component is intended for one-time use in a single surgical procedure and should not be reused on another patient to maintain sterility and safety standards.

  • How is the Stowe Pedicle Screw System regulated, and what does the Special Review process entail?

    The Stowe Pedicle Screw System received FDA 510(k) clearance under Special Review via the Orthopedic (OR) Advisory Committee. Special Review is a more rigorous pathway for devices that may pose higher risks or require additional scrutiny. The system was classified as Substantially Equivalent (SESE) to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously cleared device.

  • What surgical settings or professionals are authorized to use the Stowe Pedicle Screw System?

    The Stowe Pedicle Screw System is intended for surgical implantation by orthopedic or spinal surgeons in clinical settings. It is not designed for use in outpatient clinics or non-surgical environments but is meant for controlled operating room procedures where spinal fixation is required.

  • Are all components of the Stowe Pedicle Screw System compatible with standard spinal surgical techniques?

    Yes, the components of the Stowe Pedicle Screw System—including polyaxial screws, rods, and connectors—are engineered for compatibility with standard spinal surgical techniques. This ensures ease of integration into existing surgical workflows and procedures, allowing surgeons to use familiar methods while leveraging the system’s stabilization benefits.