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FDA 510(k)

DEPUY LOW PROFILE BONE SCREW

K-Number: K970929 · 1997-06-09

ApplicantDepuy, Inc.
Decision Date1997-06-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DEPUY LOW PROFILE BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1997-06-09 under 510(k) number K970929. 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 DEPUY LOW PROFILE BONE SCREW?

DEPUY LOW PROFILE BONE SCREW is a medical device that received FDA 510(k) clearance on 1997-06-09. The listed applicant is Depuy, Inc.. The 510(k) number is K970929.

When did DEPUY LOW PROFILE BONE SCREW receive FDA 510(k) clearance?

DEPUY LOW PROFILE BONE SCREW received FDA 510(k) clearance on 1997-06-09, under 510(k) number K970929.

Who is the listed applicant for DEPUY LOW PROFILE BONE SCREW?

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 LOW PROFILE BONE SCREW?

The FDA product code for DEPUY LOW PROFILE BONE SCREW is HWC. This falls under the Cardiovascular category.

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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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