Medicrea International SA - FDA 510(k) Cleared Devices
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
Cleared
May 24, 2022
LigaPASS™ 2.0 Ligament Augmentation System
Orthopedic
186d
Cleared
Jan 05, 2022
PASS LP™ Spinal System, CD Horizon™ Spinal System
Orthopedic
96d
Cleared
Sep 03, 2021
C-CURVE Interbody Fusion Device
Orthopedic
198d
Cleared
Oct 30, 2020
UNiD IB3D ALIF
Orthopedic
266d
Cleared
Oct 30, 2019
IB3D ALIF
Orthopedic
184d
Cleared
Jul 15, 2019
UNiD Patient-matched PLIF cage
Orthopedic
340d
Cleared
May 08, 2019
UNiD Patient specific 3D printed TLIF cage
Orthopedic
110d
Cleared
May 02, 2019
PASS LP Spinal System
Orthopedic
72d
Cleared
Oct 17, 2018
PASS LP Spinal System
Orthopedic
58d
Cleared
Apr 25, 2018
UNiD Patient Specific 3D printed cage
Orthopedic
133d
Cleared
Apr 03, 2018
LigaPASS
Orthopedic
141d
Cleared
Nov 13, 2017
IMPIX 3D Print Cages
Orthopedic
327d
Cleared
Aug 30, 2017
LigaPASS
Orthopedic
56d
Cleared
Jan 25, 2017
PASS LP Spinal System
Orthopedic
114d
Cleared
Dec 08, 2016
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
Orthopedic
125d
Cleared
Sep 23, 2016
PASS XS Spinal System
Orthopedic
200d
Cleared
Sep 02, 2016
LigaPASS
Orthopedic
172d
Cleared
Jul 29, 2016
PASS LP Spinal System
Orthopedic
46d
Cleared
Jul 11, 2016
PASS OCT Spinal System
Orthopedic
77d
Cleared
Apr 26, 2016
PASS OCT Spinal System
Orthopedic
39d
Cleared
Apr 22, 2016
PASS LP Spinal System
Orthopedic
149d
Cleared
Oct 16, 2015
PASS OCT Spinal System
Orthopedic
193d
Cleared
Mar 25, 2015
PASS LP Spinal System
Orthopedic
177d
Cleared
Jan 15, 2015
IMPIX ALIF S/A
Orthopedic
252d
Cleared
Jan 09, 2015
PASS LP SPINAL SYSTEM
Orthopedic
226d