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FDA 510(k)

DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM

K-Number: K080991 · 2008-07-02

ApplicantDePuy Orthopaedics, Inc.
Decision Date2008-07-02
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2008-07-02 under 510(k) number K080991. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM?

DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-02. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K080991.

When did DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 2008-07-02, under 510(k) number K080991.

Who is the listed applicant for DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM?

The FDA product code for DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM is KWA.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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