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Spinevision, S.A.S.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K223251Hexanium PLIFDecember 16, 2022
K221578Hexanium ACIFNovember 14, 2022
K210359Hexanium TLIFMarch 10, 2021
K193000Hexanium® ACIFOctober 20, 2020
K180437Hexanium® TLIFMay 4, 2018
K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFMay 4, 2016
K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemApril 4, 2016
K133575SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATJune 30, 2014
K130302SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIALJuly 30, 2013
K112607SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) PJune 7, 2012