Tenzing System

FDA 510(k) K102130 · Mazor Surgical Technologies , Ltd.

Substantially Equivalent

510(k) numberK102130

Submission

Device name
Tenzing System
Applicant
Mazor Surgical Technologies , Ltd.
Kfar Saba, IL
Received
July 29, 2010
Decision date
August 26, 2010
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAW – Neurological Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

Other 510(k)s with product code HAW

510(k)DeviceApplicantDecision
K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional Koh Young Technology, Inc.09/10/2026SE
K261932Leksell® Vantage Stereotactic SystemHAW · Traditional Elekta Solutions AB08/05/2026SE
K253663Zeta Navigation SystemHAW · Traditional Zeta Surgical, Inc.05/01/2026SE
K253379Stealth AXiS Cranial clinical applicationHAW · Traditional Medtronic Navigation, Inc.03/26/2026SE
K231897NeuroAlign softwareHAW · Traditional Medivis, Inc.10/21/2025SE
K251317SOLOPASS 2.0 SystemHAW · Traditional Intravent Medical Partners09/05/2025SE
K250893Ball Joint Guide Array (66295)HAW · Traditional Bayer Medical Care, Inc.09/04/2025SE
K250505Ez-FiducialsHAW · Traditional Phasor Health, LLC07/09/2025SE
K242575Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional Brain Navi Biotechnology Co., Ltd.05/23/2025SE
K241327Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional Claronav02/05/2025SE

More from Claronav

510(k)DeviceDecision
K101446Emerald Spinal SystemMNH · Traditional 01/20/2011SE
K081672C-InsightLLZ · Traditional 08/15/2008SE
K073467Spineassist SystemHAW · Traditional 05/23/2008SE
K063607Spineassist SystemHAW · Traditional 08/23/2007SE
K051676Spineassist Device with Additional AccessoriesHAW · Traditional 09/08/2005SE
K033413Spineassist DeviceHAW · Traditional 01/07/2004SE

Questions and answers

When was Tenzing System cleared by the FDA?

Tenzing System (K102130) received a 510(k) decision of Substantially Equivalent on August 26, 2010, 28 days after the submission was received.

What is the product code of K102130?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.