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

FDA 510(k) Regulatory Record - Medicrea International SA Orthopedic ✕

25 devices
1-12 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
Filters
Filter by Specialty
All25 Orthopedic 25