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FDA 510(k)

REVOIS IMPLANT SYSTEM

K-Number: K063106 · 2007-06-11

ApplicantCurasan AG
Decision Date2007-06-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REVOIS IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Curasan AG. It received FDA 510(k) clearance on 2007-06-11 under 510(k) number K063106. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVOIS IMPLANT SYSTEM?

REVOIS IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-11. The listed applicant is Curasan AG. The 510(k) number is K063106.

When did REVOIS IMPLANT SYSTEM receive FDA 510(k) clearance?

REVOIS IMPLANT SYSTEM received FDA 510(k) clearance on 2007-06-11, under 510(k) number K063106.

Who is the listed applicant for REVOIS IMPLANT SYSTEM?

The FDA 510(k) record lists Curasan AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVOIS IMPLANT SYSTEM?

The FDA product code for REVOIS IMPLANT SYSTEM is NHA.

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Other records listing Curasan AG 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.

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Related Devices (Code: NHA)

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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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