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510(k) Data Aggregation
K Number
K083582Device Name
SIGN HIP CONSTRUCT (SHC), MODEL: 701
Manufacturer
Date Cleared
2009-08-26
(265 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.
Device Description
The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.
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K Number
K043200Device Name
SIGN FIN NAIL
Manufacturer
Date Cleared
2005-02-03
(77 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.
Device Description
The SIGN Fin Nail system includes intramedullary nails, Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN Fin Nail is available with diameters of 7mm, 8mm, 9mm, 11mm, 11mm, and 12mm in the following lengths: 160mm, 190mm, 240mm and 280mm. Each nail is made from a solid type 316, ASTM F138, solid stainless steel bar with distal and proximal bends. Each nail has a hole and a slot at the proximal end to accept solid 4.5mm diameter cortical bone screws for fixation and uses rigid distal fins for rotational stability. The SIGN Fin Nail may be removed upon fracture healing.
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K Number
K022632Device Name
SIGN IM NAIL
Manufacturer
Date Cleared
2002-09-23
(47 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions and fractures in the proximal femur.
The SIGN IM Nail may be removed upon fracture healing.
Device Description
The SIGN IM Nail system includes Intramedullary nails, Interlocking Screws and Instruments. The SIGN IM Nail is manufactured from Solid Bar Stainless Steel, Type 316 as per ASTM F138. This device is available with diameters of 9mm, 11mm, 11mm, 12mm, 13mm and 14mm in the following lengths: 280mm, 300mm, 320mm, 340mm, 360mm, 380mm, 400mm. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws. Screws in a range from 25mm to 75mm in 5mm increments are supplied with the nails. Each nail uses distal and proximal bends to accommodate the shape of the femur.
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K Number
K013132Device Name
SIGN IM NAIL
Manufacturer
Date Cleared
2001-12-20
(92 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including Transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions.
The SIGN IM Nail may be removed upon fracture healing.
Device Description
The SIGN IM Nail system includes Intramedullary nails. Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN IM Nail is available with diameters of 8mm. 9mm. 10mm, 11mm, and 12mm in the following lengths: 150mm, 190mm, 270mm, 270mm, 280mm, 320mm, 320mm, 340mm, 360mm, 380mm, 400. Each nail is made from a solid type 316. ASTM F138, stainless steel bar with distal and proximal bends. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws.
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