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FDA PMA

Prosthesis, intervertebral disc

PMA Number: P050010 · 2025-09-02

ApplicantCentinel Spine, LLC
Decision Date2025-09-02
PMA NumberP050010
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 Centinel Spine, LLC. It received FDA 510(k) clearance on 2025-09-02. 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 2025-09-02. The listed applicant is Centinel Spine, LLC.

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 Centinel Spine, LLC 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

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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