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FDA 510(k)

OSTEOTRANS-OT PIN

K-Number: K073311 · 2008-05-13

ApplicantTakiron Co., Ltd.
Decision Date2008-05-13
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOTRANS-OT PIN is the device name listed in this FDA 510(k) record. The listed applicant is Takiron Co., Ltd.. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K073311. 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 OSTEOTRANS-OT PIN?

OSTEOTRANS-OT PIN is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Takiron Co., Ltd.. The 510(k) number is K073311.

When did OSTEOTRANS-OT PIN receive FDA 510(k) clearance?

OSTEOTRANS-OT PIN received FDA 510(k) clearance on 2008-05-13, under 510(k) number K073311.

Who is the listed applicant for OSTEOTRANS-OT PIN?

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

What is the FDA product code for OSTEOTRANS-OT PIN?

The FDA product code for OSTEOTRANS-OT PIN is HTY.

Related Clinical Trials

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.

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Other records listing Takiron Co., 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.

K081390BIOACTIF OSTEOTRANS INTERFENCE SCREWK073006OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEMK073312OSTEOTRANS-OT SCREWK062691COMPORUSK061881OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM

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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