Harmony Port System, Model 1907 Series

• • Terminated Z-0880-2008 FDA Unclassified (pre-2012) ·initiated 19 Dec 2007

  Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.

510(k) Number

K050706 ↗

FDA Product Code

GZT

Device Class

Class II

Regulation

21 CFR Part 882.4800

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What is the Harmony Port System Model 1907 Series used for?

  The Harmony Port System Model 1907 Series is a self-retaining retractor designed for neurosurgery. It provides surgical exposure during minimally invasive procedures by holding wound edges open via a self-locking mechanism, allowing surgeons to maintain clear access to the surgical site without manual retraction.

• What components are included in the Harmony Port System Model 1907 Series?

  The system includes the Harmony Port and accessory instruments designed to facilitate its use and rigidly fix the system during use. These components work together to maintain stable retraction in the operating room setting.

• Who uses the Harmony Port System Model 1907 Series and where is it used?

  The Harmony Port System Model 1907 Series is used by surgeons in clinical settings such as the operating room. It is intended for use during neurosurgical procedures where stable, self-retaining retraction is required.

• What is the regulatory classification and clearance pathway for the Harmony Port System Model 1907 Series?

  The Harmony Port System Model 1907 Series is classified as a Class II device and received FDA 510(k) clearance under K050706 with product code GZT. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.