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510(k) Data Aggregation
K Number
K070761Device Name
SANATMETAL NAILS AND PINS
Manufacturer
SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD.
Date Cleared
2008-02-07
(324 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for the Sanatmetal Intramedullary Nails and Pins include traumatologic implants for the intramedullary fixation of fractures of tubular bones (femur, tibia, humerus), nonunions and malunions, i.e. diaphysis fractures, sub-trochanter fractures and femoral sub-trochanter fractures combined with diaphysis fractures, extra- and intraarticular fractures.
Sanatmetal Intramedullary Nails and Pins are single use devices.
Device Description
The device is a stainless steel or titanium alloy nail for orthopaedic implantation. Depending on the model selected, the device may have none, any or all of the following features: cannulation, endcaps, slots, holes, anodized finish (titanium models only), locking screws.
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