Search Results
Found 2 results
510(k) Data Aggregation
K Number
K240084Device Name
V-STRUT® Vertebral Implant
Manufacturer
Hyprevention
Date Cleared
2024-02-09
(29 days)
Product Code
NDN, LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Hyprevention
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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).
Ask a Question
K Number
K191709Device Name
V-STRUT Vertebral Implant
Manufacturer
Hyprevention SAS
Date Cleared
2020-03-05
(253 days)
Product Code
NDN, LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Hyprevention SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with Teknimed F20® bone cement.
Device Description
V-STRUT© Vertebral Implant is part of V-STRUT© Transpedicular Vertebral System. V-STRUT© Transpedicular Vertebral System is composed of :
- V-STRUT© Vertebral Implant,
- -V-STRUT© Guide Wire,
- -V-STRUT© Instrumentation Kit.
V-STRUT© Vertebral Implant 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 exists in 2 different diameters and 5 different lengths to accommodate individual patient's anatomy of thoracic and/or lumbar vertebrae from T9 to L5.
V-STRUT© Vertebral Implant is provided sterile and is not reusable.
V-STRUT© Vertebral Implanted using specific instrumentation provided with the implant and is combined in situ with a Polymethylmethacrylate (PMMA) bone cement, F20® manufactured by Teknimed SA (K103433).
Ask a Question
Page 1 of 1