Medical Device Manufacturer · FR , Neyron

Medicrea International SA - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2015

Recent clearances: LigaPASS™ 2.0 Ligament Augmentation System, PASS LP™ Spinal System, CD Horizon™ Spinal System, C-CURVE Interbody Fusion Device

25
Total
25
Cleared
0
Denied

Medicrea International SA has 25 FDA 510(k) cleared orthopedic devices. Based in Neyron, FR.

Last cleared in 2022. Active since 2015.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Mcra, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Medicrea International SA

25 devices
1-25 of 25
Cleared May 24, 2022
LigaPASS™ 2.0 Ligament Augmentation System
K213659 · OWI
Orthopedic · 186d
Cleared Jan 05, 2022
PASS LP™ Spinal System, CD Horizon™ Spinal System
K213281 · NKB
Orthopedic · 96d
Cleared Sep 03, 2021
C-CURVE Interbody Fusion Device
K210470 · OVE
Orthopedic · 198d
Cleared Oct 30, 2020
UNiD IB3D ALIF
K200316 · MAX
Orthopedic · 266d
Cleared Oct 30, 2019
IB3D ALIF
K191134 · MAX
Orthopedic · 184d
Cleared Jul 15, 2019
UNiD Patient-matched PLIF cage
K182158 · MAX
Orthopedic · 340d
Cleared May 08, 2019
UNiD Patient specific 3D printed TLIF cage
K190092 · MAX
Orthopedic · 110d
Cleared May 02, 2019
PASS LP Spinal System
K190376 · NKB
Orthopedic · 72d
Cleared Oct 17, 2018
PASS LP Spinal System
K182240 · NKB
Orthopedic · 58d
Cleared Apr 25, 2018
UNiD Patient Specific 3D printed cage
K173782 · MAX
Orthopedic · 133d
Cleared Apr 03, 2018
LigaPASS
K173506 · OWI
Orthopedic · 141d
Cleared Nov 13, 2017
IMPIX 3D Print Cages
K163595 · MAX
Orthopedic · 327d
Cleared Aug 30, 2017
LigaPASS
K172021 · OWI
Orthopedic · 56d
Cleared Jan 25, 2017
PASS LP Spinal System
K162786 · NKB
Orthopedic · 114d
Cleared Dec 08, 2016
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
K162194 · KWQ
Orthopedic · 125d
Cleared Sep 23, 2016
PASS XS Spinal System
K160640 · NKB
Orthopedic · 200d
Cleared Sep 02, 2016
LigaPASS
K160698 · OWI
Orthopedic · 172d
Cleared Jul 29, 2016
PASS LP Spinal System
K161627 · NKB
Orthopedic · 46d
Cleared Jul 11, 2016
PASS OCT Spinal System
K161149 · NKG
Orthopedic · 77d
Cleared Apr 26, 2016
PASS OCT Spinal System
K160756 · NKG
Orthopedic · 39d
Cleared Apr 22, 2016
PASS LP Spinal System
K153413 · NKB
Orthopedic · 149d
Cleared Oct 16, 2015
PASS OCT Spinal System
K150918 · NKG
Orthopedic · 193d
Cleared Mar 25, 2015
PASS LP Spinal System
K142798 · MNH
Orthopedic · 177d
Cleared Jan 15, 2015
IMPIX ALIF S/A
K141187 · OVD
Orthopedic · 252d
Cleared Jan 09, 2015
PASS LP SPINAL SYSTEM
K141398 · NKB
Orthopedic · 226d
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