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Implanet, S.A.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254017SWINGO-3D Lumbar Cage SystemFebruary 26, 2026
K252437JAZZ Spinal SystemAugust 28, 2025
K240392JAZZ Spinal SystemMay 6, 2024
K230026SQUALEMarch 28, 2023
K192084Madison Total Knee SystemOctober 22, 2019
K191217JAZZ PFAugust 2, 2019
K182771ISS-JAZZ Screw System and JAZZ CAP SPMarch 12, 2019
K171881JAZZ Passer BandAugust 8, 2017
K170730JAZZ System, including JAZZ BandJune 9, 2017
K162764JAZZ FRAME SYSTEMJanuary 19, 2017
K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorMay 18, 2016
K153348JAZZ LOCKMarch 31, 2016
K151740JAZZ SystemAugust 27, 2015
K143759JAZZ SystemMay 7, 2015
K143731IMPLANET Spine System (ISS)April 14, 2015
K133617JAZZ SYSTEMFebruary 20, 2014
K132303IMPLANET SPINE SYSTEMOctober 10, 2013
K121541JAZZ SYSTEMSeptember 13, 2012