510(k) Report

Devices descending from K192144

1 later device reach STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—