(61 days)
The Zeta MultiZone Humeral Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.
The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral, tibial and humeral fractures. This line extension is to include a humeral nail, cross-locking screws and end caps. The humeral nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.
This document is a 510(k) summary for a medical device, specifically the Zeta MultiZone Locking Nail System. It describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is primarily a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through clinical studies. The summary focuses on equivalence in intended use, materials, designs, and operational principles to predicate devices.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.