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FDA 510(k)

DEPUY ADVANTAGE FIXATION SCREW SYSTEM

K-Number: K961234 · 1996-06-19

ApplicantDepuy, Inc.
Decision Date1996-06-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY ADVANTAGE FIXATION SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1996-06-19 under 510(k) number K961234. 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 DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

DEPUY ADVANTAGE FIXATION SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-19. The listed applicant is Depuy, Inc.. The 510(k) number is K961234.

When did DEPUY ADVANTAGE FIXATION SCREW SYSTEM receive FDA 510(k) clearance?

DEPUY ADVANTAGE FIXATION SCREW SYSTEM received FDA 510(k) clearance on 1996-06-19, under 510(k) number K961234.

Who is the listed applicant for DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

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

What is the FDA product code for DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

The FDA product code for DEPUY ADVANTAGE FIXATION SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Depuy, Inc. 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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