Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

K-Number: K161318 · 2017-03-20

ApplicantTedan Surgical Innovations, LLC
Decision Date2017-03-20
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is a medical device manufactured by Tedan Surgical Innovations, LLC. It received FDA 510(k) clearance on 2017-03-20 under approval number K161318. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is a medical device that received FDA 510(k) clearance on 2017-03-20. It is manufactured by Tedan Surgical Innovations, LLC. The 510(k) number is K161318.

When was Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems approved by the FDA?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems received FDA 510(k) clearance on 2017-03-20, under approval number K161318.

What company makes Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is manufactured by Tedan Surgical Innovations, LLC.

What is the FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

The FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is GZT.

Related Clinical Trials

NCT06840938 Physiological Manipulation and Surface Electrical Stimulation in Post Stroke Dysphagia Patients COMPLETED NCT07049419 The Impact of Environmental Controls on Mental Health COMPLETED NCT07502937 A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders. NOT_YET_RECRUITING

Related Devices (Code: GZT)

K161004Self-retaining RetractorFetzer Medical GmbH & Co. KG K172433NICO BrainPathNico Corporation K161680MEDICON Spinal Spreading SystemsMedicon EG K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH K202072MindsEye Expandable PortMinnetronix Neuro, Inc. K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.

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.

↑