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FDA 510(k)

HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)

K-Number: K955733 · 1996-11-18

ApplicantDepuy, Inc.
Decision Date1996-11-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1996-11-18 under 510(k) number K955733. 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 HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)?

HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) is a medical device that received FDA 510(k) clearance on 1996-11-18. The listed applicant is Depuy, Inc.. The 510(k) number is K955733.

When did HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) receive FDA 510(k) clearance?

HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) received FDA 510(k) clearance on 1996-11-18, under 510(k) number K955733.

Who is the listed applicant for HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)?

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 HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)?

The FDA product code for HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) is HWC. This falls under the Cardiovascular category.

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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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