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FDA 510(k)

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

K-Number: K080879 · 2008-06-24

ApplicantBioretec, Ltd.
Decision Date2008-06-24
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM is the device name listed in this FDA 510(k) record. The listed applicant is Bioretec, Ltd.. It received FDA 510(k) clearance on 2008-06-24 under 510(k) number K080879. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM?

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is Bioretec, Ltd.. The 510(k) number is K080879.

When did ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM receive FDA 510(k) clearance?

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM received FDA 510(k) clearance on 2008-06-24, under 510(k) number K080879.

Who is the listed applicant for ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM?

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

What is the FDA product code for ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM?

The FDA product code for ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM is HTY.

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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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