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FDA 510(k)

VITALLIUM HEX-DRIVE BONE SCREW SYSTEM

K-Number: K864633 · 1986-12-18

ApplicantHowmedica Corp.
Decision Date1986-12-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VITALLIUM HEX-DRIVE BONE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1986-12-18 under 510(k) number K864633. 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 VITALLIUM HEX-DRIVE BONE SCREW SYSTEM?

VITALLIUM HEX-DRIVE BONE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1986-12-18. The listed applicant is Howmedica Corp.. The 510(k) number is K864633.

When did VITALLIUM HEX-DRIVE BONE SCREW SYSTEM receive FDA 510(k) clearance?

VITALLIUM HEX-DRIVE BONE SCREW SYSTEM received FDA 510(k) clearance on 1986-12-18, under 510(k) number K864633.

Who is the listed applicant for VITALLIUM HEX-DRIVE BONE SCREW SYSTEM?

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 VITALLIUM HEX-DRIVE BONE SCREW SYSTEM?

The FDA product code for VITALLIUM HEX-DRIVE BONE SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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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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