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FDA PMA

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

PMA Number: P000013 · 2025-09-17

ApplicantHowmedica Osteonics Corp.
Decision Date2025-09-17
PMA NumberP000013
Product CodeMRA
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2025-09-17. The device is classified under product code MRA. It was reviewed by the OR advisory panel.

Frequently Asked Questions

What is the Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented?

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Howmedica Osteonics Corp..

When did Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented receive FDA 510(k) clearance?

The clearance date for Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented can be found in the official FDA records.

Who is the listed applicant for Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented?

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

What is the FDA product code for Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented?

The FDA product code for Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented is MRA.

Related Clinical Trials

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.

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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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