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FDA 510(k)

SPINEASSIST DEVICE

K-Number: K033413 · 2004-01-07

ApplicantMazor Surgical Technologies , Ltd.
Decision Date2004-01-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPINEASSIST DEVICE 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 2004-01-07 under 510(k) number K033413. 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 DEVICE?

SPINEASSIST DEVICE is a medical device that received FDA 510(k) clearance on 2004-01-07. The listed applicant is Mazor Surgical Technologies , Ltd.. The 510(k) number is K033413.

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

SPINEASSIST DEVICE received FDA 510(k) clearance on 2004-01-07, under 510(k) number K033413.

Who is the listed applicant for SPINEASSIST DEVICE?

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 DEVICE?

The FDA product code for SPINEASSIST DEVICE is HAW.

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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 SYSTEMK063607SPINEASSIST SYSTEMK051676SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES

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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.

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