FDA PMA

Prosthesis, intervertebral disc

PMA Number: P250042 · 2026-09-22

ApplicantSpineart USA, Inc.

Decision Date2026-09-22

PMA NumberP250042

Product CodeMJO

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeOR

Device Summary

Prosthesis, intervertebral disc is the device name listed in this FDA 510(k) record. The listed applicant is Spineart USA, Inc.. It received FDA 510(k) clearance on 2026-09-22. The device is classified under product code MJO. It was reviewed by the OR advisory panel.

Frequently Asked Questions

What is the Prosthesis, intervertebral disc?

Prosthesis, intervertebral disc is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Spineart USA, Inc..

When did Prosthesis, intervertebral disc receive FDA 510(k) clearance?

The clearance date for Prosthesis, intervertebral disc can be found in the official FDA records.

Who is the listed applicant for Prosthesis, intervertebral disc?

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

What is the FDA product code for Prosthesis, intervertebral disc?

The FDA product code for Prosthesis, intervertebral disc is MJO.

Related Clinical Trials

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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.