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FDA 510(k)

OSTEOTRANS-OT SCREW

K-Number: K073312 · 2008-05-13

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

Device Summary

OSTEOTRANS-OT SCREW 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 K073312. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOTRANS-OT SCREW?

OSTEOTRANS-OT SCREW 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 K073312.

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

OSTEOTRANS-OT SCREW received FDA 510(k) clearance on 2008-05-13, under 510(k) number K073312.

Who is the listed applicant for OSTEOTRANS-OT SCREW?

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 SCREW?

The FDA product code for OSTEOTRANS-OT SCREW is HWC. This falls under the Cardiovascular category.

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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 SYSTEMK073311OSTEOTRANS-OT PINK062691COMPORUSK061881OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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