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FDA 510(k)

DUPUY S-ROM STD HIP STEM PROSTHESIS

K-Number: K061221 · 2006-08-28

ApplicantDePuy Orthopaedics, Inc.
Decision Date2006-08-28
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DUPUY S-ROM STD HIP STEM PROSTHESIS 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 2006-08-28 under 510(k) number K061221. 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 DUPUY S-ROM STD HIP STEM PROSTHESIS?

DUPUY S-ROM STD HIP STEM PROSTHESIS is a medical device that received FDA 510(k) clearance on 2006-08-28. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K061221.

When did DUPUY S-ROM STD HIP STEM PROSTHESIS receive FDA 510(k) clearance?

DUPUY S-ROM STD HIP STEM PROSTHESIS received FDA 510(k) clearance on 2006-08-28, under 510(k) number K061221.

Who is the listed applicant for DUPUY S-ROM STD HIP STEM PROSTHESIS?

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 DUPUY S-ROM STD HIP STEM PROSTHESIS?

The FDA product code for DUPUY S-ROM STD HIP STEM PROSTHESIS is KWA.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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K262130ATTUNE Revision Knee SystemK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

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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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