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FDA PMA

Prosthesis, spinous process tension band implant

PMA Number: P220031 · 2026-04-08

ApplicantEmpirical Spine, Inc.
Decision Date2026-04-08
PMA NumberP220031
Product CodeSGK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Prosthesis, spinous process tension band implant is the device name listed in this FDA 510(k) record. The listed applicant is Empirical Spine, Inc.. It received FDA 510(k) clearance on 2026-04-08. The device is classified under product code SGK. It was reviewed by the OR advisory panel.

Frequently Asked Questions

What is the Prosthesis, spinous process tension band implant?

Prosthesis, spinous process tension band implant is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Empirical Spine, Inc..

When did Prosthesis, spinous process tension band implant receive FDA 510(k) clearance?

The clearance date for Prosthesis, spinous process tension band implant can be found in the official FDA records.

Who is the listed applicant for Prosthesis, spinous process tension band implant?

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

What is the FDA product code for Prosthesis, spinous process tension band implant?

The FDA product code for Prosthesis, spinous process tension band implant is SGK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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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