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FDA 510(k)

RENAISSANCE

K-Number: K120812 · 2012-07-12

ApplicantMazor Robotics , Ltd.
Decision Date2012-07-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RENAISSANCE is the device name listed in this FDA 510(k) record. The listed applicant is Mazor Robotics , Ltd.. It received FDA 510(k) clearance on 2012-07-12 under 510(k) number K120812. 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 RENAISSANCE?

RENAISSANCE is a medical device that received FDA 510(k) clearance on 2012-07-12. The listed applicant is Mazor Robotics , Ltd.. The 510(k) number is K120812.

When did RENAISSANCE receive FDA 510(k) clearance?

RENAISSANCE received FDA 510(k) clearance on 2012-07-12, under 510(k) number K120812.

Who is the listed applicant for RENAISSANCE?

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

What is the FDA product code for RENAISSANCE?

The FDA product code for RENAISSANCE is HAW.

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Other records listing Mazor Robotics , 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.

K251316Mazor X System / Mazor X Stealth EditionK230064Mazor X System (Mazor X Stealth Edition)K203005Mazor XK200935Mazor XK182077Mazor X System (Mazor X Stealth Edition)K180307Mazor X

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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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