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FDA 510(k)

HELENA SYSTEM

K-Number: K110177 · 2011-04-21

ApplicantRoyal Oak Medical Devices
Decision Date2011-04-21
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HELENA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Royal Oak Medical Devices. It received FDA 510(k) clearance on 2011-04-21 under 510(k) number K110177. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA SYSTEM?

HELENA SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-21. The listed applicant is Royal Oak Medical Devices. The 510(k) number is K110177.

When did HELENA SYSTEM receive FDA 510(k) clearance?

HELENA SYSTEM received FDA 510(k) clearance on 2011-04-21, under 510(k) number K110177.

Who is the listed applicant for HELENA SYSTEM?

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

What is the FDA product code for HELENA SYSTEM?

The FDA product code for HELENA SYSTEM is MAX.

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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Royal Oak Medical Devices as applicant

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.

K110046ATHENA PEDICLE SCREW SYSTEM

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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.

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