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FDA PMA

Osseoanchored prostheses for the rehabilitation of transfemoral amputees

PMA Number: P190009 · 2026-04-15

ApplicantIntegrum AB
Decision Date2026-04-15
PMA NumberP190009
Product CodePJY
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Osseoanchored prostheses for the rehabilitation of transfemoral amputees is the device name listed in this FDA 510(k) record. The listed applicant is Integrum AB. It received FDA 510(k) clearance on 2026-04-15. The device is classified under product code PJY. It was reviewed by the OR advisory panel.

Frequently Asked Questions

What is the Osseoanchored prostheses for the rehabilitation of transfemoral amputees?

Osseoanchored prostheses for the rehabilitation of transfemoral amputees is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Integrum AB.

When did Osseoanchored prostheses for the rehabilitation of transfemoral amputees receive FDA 510(k) clearance?

The clearance date for Osseoanchored prostheses for the rehabilitation of transfemoral amputees can be found in the official FDA records.

Who is the listed applicant for Osseoanchored prostheses for the rehabilitation of transfemoral amputees?

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

What is the FDA product code for Osseoanchored prostheses for the rehabilitation of transfemoral amputees?

The FDA product code for Osseoanchored prostheses for the rehabilitation of transfemoral amputees is PJY.

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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