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Medical technology / Prosthetics / Medical device / Medical equipment / Food law / Premarket approval / Center for Devices and Radiological Health / Sacroiliac joint dysfunction / Sacroiliac joint / Medicine / Health / Food and Drug Administration


K141049 510(k) SUMMARY - iFuse Implant System®
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Document Date: 2014-08-08 12:37:34

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File Size: 102,57 KB

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City

San Jose / /

Company

SI-BONE Inc. / /

/

Event

FDA Phase / /

Facility

New Hampshire Avenue lDocumnent Control Center / /

IndustryTerm

announcements concerning your device / predicate device / Internet address littp /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / hUIJMAN SERVICESPulcIe. / Srve Food and Drag Administration / office of Device Evaluation / New Hampshire Avenue lDocumnent Control Center / FDA / Device Evaluation Center for Devices / Division of Orthopedic Devices / Mark N. Melkerson Director Division / CDRH's office of Surveillance / /

Person

Lori A.Wiggins / Roxanne Dubois / Mark N. Melkerson / /

/

Position

VP / Regulatory and Quality / Vice President / Regulatory Affairs and Quality Assurance / /

Product

Federal Food / /

ProgrammingLanguage

D / /

ProvinceOrState

California / /

Technology

radiation / ADO / /

URL

www.fda.uov/Medicalflevices/Safetv/ReoorlaProbleim/def'ault.litm / www.fda.uov/MedicalDevices/ResourcesforYou/lndustry/default.litm / www.fda.q-ov/Medicalflevices/ResourcesforYou/industr/dfault.htm / /

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