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FDA 510(k)

5/8 POROCOAT AML HIP POROCOAT POROUS COATING

K-Number: K941847 · 1994-07-12

ApplicantDepuy, Inc.
Decision Date1994-07-12
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

5/8 POROCOAT AML HIP POROCOAT POROUS COATING is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K941847. 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 5/8 POROCOAT AML HIP POROCOAT POROUS COATING?

5/8 POROCOAT AML HIP POROCOAT POROUS COATING is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Depuy, Inc.. The 510(k) number is K941847.

When did 5/8 POROCOAT AML HIP POROCOAT POROUS COATING receive FDA 510(k) clearance?

5/8 POROCOAT AML HIP POROCOAT POROUS COATING received FDA 510(k) clearance on 1994-07-12, under 510(k) number K941847.

Who is the listed applicant for 5/8 POROCOAT AML HIP POROCOAT POROUS COATING?

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 5/8 POROCOAT AML HIP POROCOAT POROUS COATING?

The FDA product code for 5/8 POROCOAT AML HIP POROCOAT POROUS COATING is LZO.

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Other records listing Depuy, Inc. as applicant

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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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