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FDA 510(k)

TENZING SYSTEM

K-Number: K102130 · 2010-08-26

ApplicantMazor Surgical Technologies , Ltd.
Decision Date2010-08-26
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENZING 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 2010-08-26 under 510(k) number K102130. 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 TENZING SYSTEM?

TENZING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-26. The listed applicant is Mazor Surgical Technologies , Ltd.. The 510(k) number is K102130.

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

TENZING SYSTEM received FDA 510(k) clearance on 2010-08-26, under 510(k) number K102130.

Who is the listed applicant for TENZING 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 TENZING SYSTEM?

The FDA product code for TENZING SYSTEM 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 SYSTEMK081672C-INSIGHTK073467SPINEASSIST SYSTEMK063607SPINEASSIST SYSTEMK051676SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIESK033413SPINEASSIST DEVICE

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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.

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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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