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FDA 510(k)

6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW

K-Number: K944213 · 1994-12-09

ApplicantHowmedica Corp.
Decision Date1994-12-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K944213. 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 for Some Indications.

Frequently Asked Questions

What is the 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW?

6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Howmedica Corp.. The 510(k) number is K944213.

When did 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW receive FDA 510(k) clearance?

6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW received FDA 510(k) clearance on 1994-12-09, under 510(k) number K944213.

Who is the listed applicant for 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW?

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

What is the FDA product code for 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW?

The FDA product code for 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: HWC)

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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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