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FDA 510(k)

ESKA MODULAR HIP SYSTEM CEMENTED

K-Number: K030867 · 2003-09-22

ApplicantEska Implants GmbH
Decision Date2003-09-22
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ESKA MODULAR HIP SYSTEM CEMENTED is the device name listed in this FDA 510(k) record. The listed applicant is Eska Implants GmbH. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K030867. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESKA MODULAR HIP SYSTEM CEMENTED?

ESKA MODULAR HIP SYSTEM CEMENTED is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Eska Implants GmbH. The 510(k) number is K030867.

When did ESKA MODULAR HIP SYSTEM CEMENTED receive FDA 510(k) clearance?

ESKA MODULAR HIP SYSTEM CEMENTED received FDA 510(k) clearance on 2003-09-22, under 510(k) number K030867.

Who is the listed applicant for ESKA MODULAR HIP SYSTEM CEMENTED?

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

What is the FDA product code for ESKA MODULAR HIP SYSTEM CEMENTED?

The FDA product code for ESKA MODULAR HIP SYSTEM CEMENTED is JDI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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