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FDA 510(k)

BIO-INTRAFIX TIBIAL SCREW AND SHEATH

K-Number: K032167 · 2003-10-15

ApplicantMitek Worldwide
Decision Date2003-10-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO-INTRAFIX TIBIAL SCREW AND SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Worldwide. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K032167. 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 BIO-INTRAFIX TIBIAL SCREW AND SHEATH?

BIO-INTRAFIX TIBIAL SCREW AND SHEATH is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Mitek Worldwide. The 510(k) number is K032167.

When did BIO-INTRAFIX TIBIAL SCREW AND SHEATH receive FDA 510(k) clearance?

BIO-INTRAFIX TIBIAL SCREW AND SHEATH received FDA 510(k) clearance on 2003-10-15, under 510(k) number K032167.

Who is the listed applicant for BIO-INTRAFIX TIBIAL SCREW AND SHEATH?

The FDA 510(k) record lists Mitek Worldwide as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-INTRAFIX TIBIAL SCREW AND SHEATH?

The FDA product code for BIO-INTRAFIX TIBIAL SCREW AND SHEATH is HWC. This falls under the Cardiovascular category.

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Other records listing Mitek Worldwide 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.

K032717BIOCRYL RAPIDE INTERFERENCE SCREWK032078MITEK MICRO QUICKANCHORK030995MINILOK QUICKANCHOR PLUSK031519CUFFLOK ANCHORK031406EXOJET TISSUE MANAGEMENT SYSTEMK024115MICROFIX QUICKANCHOR PLUS

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Related Devices (Code: HWC)

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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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