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FDA 510(k)

TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM

K-Number: K952697 · 1995-09-12

ApplicantSmith & Nephew Richards, Inc.
Decision Date1995-09-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K952697. 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 TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM?

TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K952697.

When did TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM receive FDA 510(k) clearance?

TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM received FDA 510(k) clearance on 1995-09-12, under 510(k) number K952697.

Who is the listed applicant for TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM?

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

What is the FDA product code for TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM?

The FDA product code for TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Smith & Nephew Richards, 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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