Medical Device Manufacturer · FR , Neyron

Medicrea International SA

25 submissions · 25 cleared · Since 2015
25
Total
25
Cleared
0
Denied

Medicrea International SA — FDA 510(k) Submissions

Medicrea International SA has submitted 25 FDA 510(k) premarket notifications since 2015, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Lumbar, Bone Fixation Cerclage, Sublaminar, Posterior Cervical Screw System, Intervertebral Fusion Device With Integrated Fixation, Lumbar . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
LigaPASS? 2.0 Ligament Augmentation System
K213659 · OWI Bone Fixation Cerclage,... · Orthopedic
May 2022 186d
PASS LP? Spinal System, CD Horizon? Spinal System
K213281 · NKB Thoracolumbosacral... · Orthopedic
Jan 2022 96d
C-CURVE Interbody Fusion Device
K210470 · OVE Intervertebral Fusion... · Orthopedic
Sep 2021 198d
UNiD IB3D ALIF
K200316 · MAX Intervertebral Fusion... · Orthopedic
Oct 2020 266d
IB3D ALIF
K191134 · MAX Intervertebral Fusion... · Orthopedic
Oct 2019 184d
UNiD Patient-matched PLIF cage
K182158 · MAX Intervertebral Fusion... · Orthopedic
Jul 2019 340d
UNiD Patient specific 3D printed TLIF cage
K190092 · MAX Intervertebral Fusion... · Orthopedic
May 2019 110d
PASS LP Spinal System
K190376 · NKB Thoracolumbosacral... · Orthopedic
May 2019 72d
PASS LP Spinal System
K182240 · NKB Thoracolumbosacral... · Orthopedic
Oct 2018 58d
UNiD Patient Specific 3D printed cage
K173782 · MAX Intervertebral Fusion... · Orthopedic
Apr 2018 133d
LigaPASS
K173506 · OWI Bone Fixation Cerclage,... · Orthopedic
Apr 2018 141d
IMPIX 3D Print Cages
K163595 · MAX Intervertebral Fusion... · Orthopedic
Nov 2017 327d
LigaPASS
K172021 · OWI Bone Fixation Cerclage,... · Orthopedic
Aug 2017 56d
PASS LP Spinal System
K162786 · NKB Thoracolumbosacral... · Orthopedic
Jan 2017 114d
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
K162194 · KWQ Appliance, Fixation,... · Orthopedic
Dec 2016 125d
PASS XS Spinal System
K160640 · NKB Thoracolumbosacral... · Orthopedic
Sep 2016 200d
LigaPASS
K160698 · OWI Bone Fixation Cerclage,... · Orthopedic
Sep 2016 172d
PASS LP Spinal System
K161627 · NKB Thoracolumbosacral... · Orthopedic
Jul 2016 46d
PASS OCT Spinal System
K161149 · NKG Posterior Cervical Screw... · Orthopedic
Jul 2016 77d
PASS OCT Spinal System
K160756 · NKG Posterior Cervical Screw... · Orthopedic
Apr 2016 39d
PASS LP Spinal System
K153413 · NKB Thoracolumbosacral... · Orthopedic
Apr 2016 149d
PASS OCT Spinal System
K150918 · NKG Posterior Cervical Screw... · Orthopedic
Oct 2015 193d
PASS LP Spinal System
K142798 · MNH Orthosis,... · Orthopedic
Mar 2015 177d
IMPIX ALIF S/A
K141187 · OVD Intervertebral Fusion... · Orthopedic
Jan 2015 252d
PASS LP SPINAL SYSTEM
K141398 · NKB Thoracolumbosacral... · Orthopedic
Jan 2015 226d
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