FDA 510(k), K230857, TiLink-P SI Joint Fusion System
FDA 510(k), K230857, TiLink-P SI Joint Fusion System
510(K) Number: K230857
Device Name: TiLink-P SI Joint Fusion System
Manufacturer: Andrew Shoup
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: KXA
Date Received: 03/29/2023
Decision Date: 09/25/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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