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FDA PMA

Stimulator, bone growth, non-invasive

PMA Number: P210016 · 2025-01-17

ApplicantEnovis
Decision Date2025-01-17
PMA NumberP210016
Product CodeLOF
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Stimulator, bone growth, non-invasive is the device name listed in this FDA 510(k) record. The listed applicant is Enovis. It received FDA 510(k) clearance on 2025-01-17. The device is classified under product code LOF. It was reviewed by the OR advisory panel.

Frequently Asked Questions

What is the Stimulator, bone growth, non-invasive?

Stimulator, bone growth, non-invasive is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Enovis.

When did Stimulator, bone growth, non-invasive receive FDA 510(k) clearance?

The clearance date for Stimulator, bone growth, non-invasive can be found in the official FDA records.

Who is the listed applicant for Stimulator, bone growth, non-invasive?

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

What is the FDA product code for Stimulator, bone growth, non-invasive?

The FDA product code for Stimulator, bone growth, non-invasive is LOF.

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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