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FDA PMA

Prosthesis, posterior spinal elements

PMA Number: P220002 · 2026-09-09

ApplicantPremia Spine, Ltd.
Decision Date2026-09-09
PMA NumberP220002
Product CodeQWK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Prosthesis, posterior spinal elements is the device name listed in this FDA 510(k) record. The listed applicant is Premia Spine, Ltd.. It received FDA 510(k) clearance on 2026-09-09. The device is classified under product code QWK. It was reviewed by the OR advisory panel.

Frequently Asked Questions

What is the Prosthesis, posterior spinal elements?

Prosthesis, posterior spinal elements is a medical device that received FDA 510(k) clearance on 2026-09-09. The listed applicant is Premia Spine, Ltd..

When did Prosthesis, posterior spinal elements receive FDA 510(k) clearance?

The clearance date for Prosthesis, posterior spinal elements can be found in the official FDA records.

Who is the listed applicant for Prosthesis, posterior spinal elements?

The FDA 510(k) record lists Premia Spine, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosthesis, posterior spinal elements?

The FDA product code for Prosthesis, posterior spinal elements is QWK.

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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