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510(k) Data Aggregation
K Number
K030665Device Name
BONE WIRE
Manufacturer
STORK INSTRUMENTE GMBH
Date Cleared
2003-03-25
(22 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
STORK INSTRUMENTE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Störk Instrumente GmbH's Bone Wires is the fixation of bone fractures and / or to guide other implants during insertion to the skeletal system.
Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.
Störk Instrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.
Störk Instrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.
Device Description
Trade Name: Bone Wire Common Name: Kirschner Wire (K wire), Steinmann Wire, Bonell Wire (Pin), Cerclage Wire
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