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FDA 510(k)

ACTIVAPIN

K-Number: K061164 · 2006-07-06

ApplicantBioretec, Ltd.
Decision Date2006-07-06
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIVAPIN is the device name listed in this FDA 510(k) record. The listed applicant is Bioretec, Ltd.. It received FDA 510(k) clearance on 2006-07-06 under 510(k) number K061164. 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?

ACTIVAPIN is a medical device that received FDA 510(k) clearance on 2006-07-06. The listed applicant is Bioretec, Ltd.. The 510(k) number is K061164.

When did ACTIVAPIN receive FDA 510(k) clearance?

ACTIVAPIN received FDA 510(k) clearance on 2006-07-06, under 510(k) number K061164.

Who is the listed applicant for ACTIVAPIN?

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?

The FDA product code for ACTIVAPIN is HTY.

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Other records listing Bioretec, Ltd. 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.

K261057ActivaScrew™ Cannulated COMK130716BIORETEC ACTIVASCREW INTERFERENCEK080879ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTMK081392BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPINK072848ACTIVASCREWK071863ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

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Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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