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Found 3 results
510(k) Data Aggregation
K Number
K052576Device Name
SBI AUTOFIX
Manufacturer
SMALL BONE INNOVATIONS, LLC
Date Cleared
2005-11-07
(49 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
SMALL BONE INNOVATIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.
Device Description
The SBI AutoFix™ System consists of a series of Cannulated and Non-Cannulated bone screws varying in length and diameter. The SBI AutoFix™ System is intended for use on selected fractures in the body as medically indicated and bone mass compatible.
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K Number
K051747Device Name
SBI WRISTFIT
Manufacturer
SMALL BONE INNOVATIONS, LLC
Date Cleared
2005-09-06
(69 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SMALL BONE INNOVATIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SBI WristFIT™ (Fracture In Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small and long bones. This includes:
- . distal radius fractures
- t distal ulna fractures
- . radial osteotomies
- . radial fusions
- . tarsal fractures
Device Description
The system features non-sterile stainless steel plates with cortical locking, non-locking, and Cannulated screws in two diameters (2.4mm and 2.7mm), high angle screws with low profile heads when inserted into specially designed screw holes at angles as high as 60° to 70° off perpendicular, or 30° to 70° from the plate or bone axis, and the instruments with which to implant them.
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K Number
K051605Device Name
SBI K-WIRES
Manufacturer
SMALL BONE INNOVATIONS, LLC
Date Cleared
2005-08-10
(55 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
SMALL BONE INNOVATIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SBI K-Wires are indicated for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
Device Description
SBI K-Wires are provided non-sterile. They range in diameter from 0.9mm - 2.0mm and are 150mm long. They are available in single point, double point, and threaded single point.
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