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FDA 510(k)

PROFEMUR RENAISSANCE HIP STEM

K-Number: K051995 · 2005-08-22

ApplicantWrightmedicaltechnologyinc
Decision Date2005-08-22
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR RENAISSANCE HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2005-08-22 under 510(k) number K051995. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFEMUR RENAISSANCE HIP STEM?

PROFEMUR RENAISSANCE HIP STEM is a medical device that received FDA 510(k) clearance on 2005-08-22. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K051995.

When did PROFEMUR RENAISSANCE HIP STEM receive FDA 510(k) clearance?

PROFEMUR RENAISSANCE HIP STEM received FDA 510(k) clearance on 2005-08-22, under 510(k) number K051995.

Who is the listed applicant for PROFEMUR RENAISSANCE HIP STEM?

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

What is the FDA product code for PROFEMUR RENAISSANCE HIP STEM?

The FDA product code for PROFEMUR RENAISSANCE HIP STEM is JDL.

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Related Devices (Code: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, Inc.K041586PROFEMUR S 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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