Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPINEASSIST SYSTEM

K-Number: K063607 · 2007-08-23

ApplicantMazor Surgical Technologies , Ltd.
Decision Date2007-08-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPINEASSIST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mazor Surgical Technologies , Ltd.. It received FDA 510(k) clearance on 2007-08-23 under 510(k) number K063607. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINEASSIST SYSTEM?

SPINEASSIST SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-23. The listed applicant is Mazor Surgical Technologies , Ltd.. The 510(k) number is K063607.

When did SPINEASSIST SYSTEM receive FDA 510(k) clearance?

SPINEASSIST SYSTEM received FDA 510(k) clearance on 2007-08-23, under 510(k) number K063607.

Who is the listed applicant for SPINEASSIST SYSTEM?

The FDA 510(k) record lists Mazor Surgical Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINEASSIST SYSTEM?

The FDA product code for SPINEASSIST SYSTEM is HAW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mazor Surgical Technologies , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101446EMERALD SPINAL SYSTEMK102130TENZING SYSTEMK081672C-INSIGHTK073467SPINEASSIST SYSTEMK051676SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIESK033413SPINEASSIST DEVICE

View all 7 devices →

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑