Search Results
Found 3 results
510(k) Data Aggregation
K Number
K083648Device Name
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
Manufacturer
EFRATGO, LTD. HI TECH BIO-SURGICAL
Date Cleared
2009-05-14
(156 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
EFRATGO, LTD. HI TECH BIO-SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.
Device Description
The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and up to two distal locking bolts.
Ask a Question
K Number
K043233Device Name
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
Manufacturer
EFRATGO, LTD. HI TECH BIO-SURGICAL
Date Cleared
2005-02-01
(71 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
EFRATGO, LTD. HI TECH BIO-SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, and base of neck fractures of the proximal femur.
Device Description
The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and two distal locking bolts.
Ask a Question
K Number
K983814Device Name
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
Manufacturer
EFRATGO, LTD. HI TECH BIO-SURGICAL
Date Cleared
1999-01-14
(78 days)
Product Code
JDO
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
EFRATGO, LTD. HI TECH BIO-SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.
Device Description
The GOTFRIED PC.C.P system is a plate and screw system, made of stainless steel, which utilizes dynamic femoral neck screws. The plate accepts two neck screws (length ranging from 90 mm to 140 mm) having barrel (sleeve) diameter of 9.3 mm and shaft diameter of 6.4 mm, and three 4.5 mm cortical screws (length ranging from 31 to 43 mm).
Ask a Question
Page 1 of 1