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510(k) Data Aggregation
K Number
K130627Device Name
SWING-OFF SCREW
Manufacturer
Date Cleared
2013-08-21
(166 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED INTERVENTIONAL TECHNOLOGY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BRM SWING-OFF SCREW is indicated for surgical fixation of bone fractures, osteotomies and bone reconstruction in order to position and maintain bony fragments in a desired orientation and to provide stable fixation of the osteotomy site until a stable bony union occurs.
Examples include but are not limited to:
-Fixation of small bone fragments
-Weil osteotomy
-Mono-cortical fixation
-Osteotomies and fractures fixation in foot and hand
Device Description
The BRM SWING OFF Screw is made of titanium alloy (Ti6A14V- ELI) according to ISO 5832-3 and ASTM F 136. It is self-drilling and self-tapping and consists of a screw with a flat thin head which is integrated with a short round shaft. The shaft is fixed on a standard surgical shaft and separates from the screw when the head comes in contact with cortical bone.
The screw is available in two different diameters (2.0 and 2.7 mm) and in length from 10 to 15 mm for Ø 2.0 mm and from 10 to 17 mm for Ø 2.7 mm. The screws are anodized and color-coded (yellow) to be easily recognized. The head design facilitates maximum loading and compression. The self-drilling tip easily penetrates the cortical shell. A Swing-Off Terminal Screw Driver is offered for ease of use.
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K Number
K130954Device Name
ARS SCREW; SLANT SCREW
Manufacturer
Date Cleared
2013-05-31
(56 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED INTERVENTIONAL TECHNOLOGY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to:
· Fixation of bone fragments in long or small bone fractures
· arthrodesis in hand or foot surgery
· mono or bi-cortical osteotomies in the foot or hand
· distal or proximal metatarsal or metacarpal osteotomies
· fixation of osteotomies for hallux valgus treatment (such as Scarf, Chevron, etc.)
Device Description
The ARS and SLANT Screws are made of titanium alloy (Ti6A14V) according to ISO 5832-3 and ASTM F 136. They are self-drilling, self-tapping and designed with a double thread for better grip on tissue. The ARS and SLANT Screws are intended for single use only.
The titanium ARS and SLANT SCREWs are cannulated for use with a guide wire and have double-threading and different pitch for the proximal and distal threads. The headless screws can be completely embedded in the bone thus avoiding any protrusion that could cause irritation to the tissue. The double-thread design assures compression and stability of the fractures. Both screws have reverse-cutting flutes in the head threaded portion to facilitate removal of the screw.
The code to clearly identify each product is laser-marked on the unthreaded cylindrical screw part. The screws are color coded (anodized) to be easily recognized ARS (blue) from SLANT (green).
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