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FDA 510(k)

CERAMIC FEMORAL HEAD

K-Number: K893685 · 1989-09-26

ApplicantDow Corning Wright
Decision Date1989-09-26
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K893685. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAMIC FEMORAL HEAD?

CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Dow Corning Wright. The 510(k) number is K893685.

When did CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 1989-09-26, under 510(k) number K893685.

Who is the listed applicant for CERAMIC FEMORAL HEAD?

The FDA 510(k) record lists Dow Corning Wright as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERAMIC FEMORAL HEAD?

The FDA product code for CERAMIC FEMORAL HEAD is LZO.

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Other records listing Dow Corning Wright as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932210ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENTK932911ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENTK934354LACEY ALL POLYETHYLENE TIBIAL COMPONENTK932222SLT FEMORAL HEADK932858ORTHOLOC ADVANTIM TIBIAL BASE COMPONENTK930228ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE

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Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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