Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

FDA 510(k) K161318 · Tedan Surgical Innovations, LLC

Substantially Equivalent

510(k) numberK161318

Submission

Device name
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
Applicant
Tedan Surgical Innovations, LLC
Sugar Land, TX, US
Received
May 11, 2016
Decision date
March 20, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GZT – Retractor, Self-Retaining, For Neurosurgery
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4800
Specialty
Neurology

Other 510(k)s with product code GZT

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K202072MindsEye Expandable PortGZT · Traditional Minnetronix Neuro, Inc.08/26/2020SE
K180610Geister retractor for neuro - and spine surgeryGZT · Traditional Geister Medizin Technik GmbH08/29/2018SE
K172433NICO BrainPathGZT · Special Nico Corporation09/07/2017SE
K161680MEDICON Spinal Spreading SystemsGZT · Traditional Medicon EG03/24/2017SE
K161004Self-retaining RetractorGZT · Traditional Fetzer Medical GmbH & Co. KG09/09/2016SE
K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional Nico Corporation06/12/2015SE
K120691Brain PortGZT · Traditional Nico Corporation06/05/2012SE
K113273Spotlight Access SystemGZT · Traditional Johnson & Johnson01/27/2012SE

More from Johnson & Johnson

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K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…PDQ · Traditional 04/26/2026SE
K231691Phantom XL Insulated DilatorsGXZ · Special 06/29/2023SE
K140088Phantom XL Insulated DilatorsPDQ · Traditional 09/25/2014SE

Questions and answers

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

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems (K161318) received a 510(k) decision of Substantially Equivalent on March 20, 2017, 313 days after the submission was received.

What is the product code of K161318?

The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.