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FDA 510(k)

C-INSIGHT

K-Number: K081672 · 2008-08-15

ApplicantMazor Surgical Technologies , Ltd.
Decision Date2008-08-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C-INSIGHT 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 2008-08-15 under 510(k) number K081672. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-INSIGHT?

C-INSIGHT is a medical device that received FDA 510(k) clearance on 2008-08-15. The listed applicant is Mazor Surgical Technologies , Ltd.. The 510(k) number is K081672.

When did C-INSIGHT receive FDA 510(k) clearance?

C-INSIGHT received FDA 510(k) clearance on 2008-08-15, under 510(k) number K081672.

Who is the listed applicant for C-INSIGHT?

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 C-INSIGHT?

The FDA product code for C-INSIGHT is LLZ.

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Other records listing Mazor Surgical Technologies , Ltd. as applicant

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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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