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IFUSE IMPLANT SYSTEM — SI-BONE, Inc. (510(k) K131405)

IFUSE IMPLANT SYSTEM — SI-BONE, Inc. (510(k) K131405) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: IFUSE IMPLANT SYSTEM; Applicant: SI-BONE, Inc.; Clearance track: 510(k).

Device nameIFUSE IMPLANT SYSTEM
ApplicantSI-BONE, Inc.
Clearance track510(k)
Submission numberK131405
DecisionSubstantially Equivalent
Decision date2013-10-16
Date received2013-05-15
Product codeOUR
Device class2
Medical specialtyOrthopedic
Applicant locationCA, US
SourceopenFDA device

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