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FDA 510(k)

BIORETEC ACTIVASCREW INTERFERENCE

K-Number: K130716 · 2013-08-28

ApplicantBioretec, Ltd.
Decision Date2013-08-28
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIORETEC ACTIVASCREW INTERFERENCE is the device name listed in this FDA 510(k) record. The listed applicant is Bioretec, Ltd.. It received FDA 510(k) clearance on 2013-08-28 under 510(k) number K130716. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIORETEC ACTIVASCREW INTERFERENCE?

BIORETEC ACTIVASCREW INTERFERENCE is a medical device that received FDA 510(k) clearance on 2013-08-28. The listed applicant is Bioretec, Ltd.. The 510(k) number is K130716.

When did BIORETEC ACTIVASCREW INTERFERENCE receive FDA 510(k) clearance?

BIORETEC ACTIVASCREW INTERFERENCE received FDA 510(k) clearance on 2013-08-28, under 510(k) number K130716.

Who is the listed applicant for BIORETEC ACTIVASCREW INTERFERENCE?

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 BIORETEC ACTIVASCREW INTERFERENCE?

The FDA product code for BIORETEC ACTIVASCREW INTERFERENCE is MAI.

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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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