Search Results

V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine. It is intended to be used in combination with Teknimed F20® bone cement.

V-STRUT© Vertebral Implant 4.5mm diameter is part of V-STRUT© Transpedicular Vertebral System.

V-STRUT© Transpedicular Vertebral System is composed of:

• V-STRUT© Vertebral Implant (K191709, Class II),
• V-STRUT© Guide Wire (Class I),
• V-STRUT© Instrumentation Set (Class I).

V-STRUT© Vertebral Implant 4.5mm diameter is a medical device to be placed in the vertebrae through a minimally invasive procedure.
Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior
vertebral body wall.

The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers
made of tantalum (as per ASTM F560).

V-STRUT© Vertebral Implant 4.5mm diameter exists in different lengths to accommodate individual patient's anatomy of thoracic and/or
lumbar vertebrae. It is provided sterile. It is implanted using specific instrumentation provided with the implant (V-STRUT® Guide Wire
and V-STRUT© Instrumentation Set).

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called V-STRUT® Vertebral Implant.

This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested table and information based on the given input.

Ask a specific question about this device