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FDA 510(k)

IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS

K-Number: K934590 · 1995-06-14

ApplicantSmith & Nephew Richards, Inc.
Decision Date1995-06-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS 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 1995-06-14 under 510(k) number K934590. 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 IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS?

IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS is a medical device that received FDA 510(k) clearance on 1995-06-14. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K934590.

When did IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS receive FDA 510(k) clearance?

IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS received FDA 510(k) clearance on 1995-06-14, under 510(k) number K934590.

Who is the listed applicant for IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS?

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 IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS?

The FDA product code for IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS 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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