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FDA 510(k)

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

K-Number: K071863 · 2007-08-31

ApplicantBioretec, Ltd.
Decision Date2007-08-31
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) is the device name listed in this FDA 510(k) record. The listed applicant is Bioretec, Ltd.. It received FDA 510(k) clearance on 2007-08-31 under 510(k) number K071863. 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 ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)?

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) is a medical device that received FDA 510(k) clearance on 2007-08-31. The listed applicant is Bioretec, Ltd.. The 510(k) number is K071863.

When did ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) receive FDA 510(k) clearance?

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) received FDA 510(k) clearance on 2007-08-31, under 510(k) number K071863.

Who is the listed applicant for ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)?

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 ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)?

The FDA product code for ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) is HTY.

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Other records listing Bioretec, 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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