FDA 510(k) Partial Contents, K131405, IFUSE IMPLANT SYSTEM
FDA 510(k) Partial Contents, K131405, IFUSE IMPLANT SYSTEM
Contents: 510k K131405 Requesting only Sections 11 Device Description 19 Performance Testing - Bench SI-BONE, Inc.
510(K) Number: K131405
Device Name: IFUSE IMPLANT SYSTEM
Manufacturer: SI-BONE, INC.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 05/15/2013
Decision Date: 10/16/2013
Regulation Medical Specialty: Orthopedic
Total pages: 54
Fully redacted pages: 42
Content pages: 12
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