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FDA 510(k)

OPTECURE +CCC

K-Number: K061668 · 2006-09-12

ApplicantExactech, Inc.
Decision Date2006-09-12
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTECURE +CCC is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2006-09-12 under 510(k) number K061668. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTECURE +CCC?

OPTECURE +CCC is a medical device that received FDA 510(k) clearance on 2006-09-12. The listed applicant is Exactech, Inc.. The 510(k) number is K061668.

When did OPTECURE +CCC receive FDA 510(k) clearance?

OPTECURE +CCC received FDA 510(k) clearance on 2006-09-12, under 510(k) number K061668.

Who is the listed applicant for OPTECURE +CCC?

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

What is the FDA product code for OPTECURE +CCC?

The FDA product code for OPTECURE +CCC is MBP.

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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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