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510(k) Data Aggregation
K Number
K161254Device Name
Renovo Life Small Bone IM Nail System
Manufacturer
Renovo Life LLC
Date Cleared
2016-11-07
(188 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
Renovo Life LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.
Device Description
The Renovo Life Small Bone IM Nail System nails are available in diameters ranging from 2.5 mm to 4.5 mm with a length of 150 mm and either solid or cannulated and materials are surgical grade stainless steel or titanium. Renovo Life Screws are 3.5 mm in diameter and are available in lengths from 10mm to 34 mm in materials of surgical grade stainless steel or titanium. The Renovo Life Small Bone IM Nail System is provided non-sterile and are intended for single use only.
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K Number
K151661Device Name
Renovo Life Hard Carbon Coated Drill Bit
Manufacturer
Renovo Life LLC
Date Cleared
2016-01-15
(210 days)
Product Code
HTW
Regulation Number
888.4540Why did this record match?
Applicant Name (Manufacturer) :
Renovo Life LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.
Device Description
Renovo Life Hard Carbon Coated Drill Bits are available in diameters ranging from 1.1 mm to 8.0 mm, lengths ranging from 60 mm to 300 mm, and either solid or cannulated. The drill bits are designed with a standard connections.
Renovo Life Hard Carbon Coated Drill Bits are made of surgical grade stainless steel. The bone-cutting portion of the drill is coated with a hard carbon coating.
Renovo Life Hard Carbon Coated Drill Bits are provided non-sterile and are intended for single use only.
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