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Endoscopic Spine System

by Arthro Kinetics, Inc.

510(k) K061246

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 NumberK061246 Date23 Aug 2006ClearedStatusActive

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Endoscopic Spine System is a reusable, minimally invasive spinal access system intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as nucleotomy, discectomy, and foraminotomy. It comprises an endoscope, light source, light guide, sheaths, camera head, and camera control unit.

The system functions by inserting an outer sheath into a cannulated incision, which serves as an access portal for the endoscope and manual surgical instruments. It is supplied as a reusable device and was cleared via the FDA 510(k) pathway under K061246 with product code HRX. The device is manufactured by Arthro Kinetics, Inc. and received FDA clearance on August 23, 2006.

Other devices from Arthro Kinetics, Inc.

Questions

AI-generated answers, 26 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 is the Endoscopic Spine System used for?

    The Endoscopic Spine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as nucleotomy, discectomy, and foraminotomy, enabling minimally invasive spinal access.

  • Is the Endoscopic Spine System reusable or single-use?

    The Endoscopic Spine System is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures, as indicated in its description and regulatory documentation.

  • What components are included in the Endoscopic Spine System?

    The system comprises an endoscope, light source, light guide, sheaths, camera head, and camera control unit, which work together to provide visualization and access during spinal procedures.

  • How was the Endoscopic Spine System cleared for market?

    The device was cleared via the FDA 510(k) pathway under submission K061246 with product code HRX, receiving FDA clearance on August 23, 2006, as a substantially equivalent device to a predicate.

  • Who manufactures the Endoscopic Spine System and where is it located?

    The Endoscopic Spine System is manufactured by Arthro Kinetics, Inc., located at 49 Plain St., North Attleboro, MA 02760, United States, as specified in the device’s authorization and manufacturer details.