Medicrea International

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
43
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1039-2026Class IIMedicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174October 29, 2025
Z-1038-2026Class IIMedicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000October 29, 2025
Z-1118-2025Class IIUNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 036137202December 3, 2024
Z-2452-2023Class IIIMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062July 12, 2023
Z-2454-2023Class IIIMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbarJuly 12, 2023
Z-2461-2023Class IIIMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B153July 12, 2023
Z-2458-2023Class IIPASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B023July 12, 2023
Z-2459-2023Class IIGRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A131July 12, 2023
Z-2456-2023Class IIIMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B201July 12, 2023
Z-2457-2023Class IIIMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) BJuly 12, 2023
Z-2460-2023Class IIIMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B2024July 12, 2023
Z-2455-2023Class IIIMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B161July 12, 2023
Z-2453-2023Class IIIMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; interveJuly 12, 2023
Z-2462-2023Class IIIMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20July 12, 2023
Z-0463-2021Class IIMEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stOctober 8, 2020
Z-1472-2020Class IIPedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B3600454January 28, 2020
Z-1473-2020Class IIIliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 January 28, 2020
Z-1234-2020Class IIMedicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : ANovember 11, 2019
Z-1156-2020Class IIMedicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200October 2, 2019
Z-0827-2020Class IIMedicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130September 16, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K213659LigaPASS™ 2.0 Ligament Augmentation SystemMay 24, 2022
K220810Infinity™ OCT System and PASS OCT Spinal SystemApril 19, 2022
K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemApril 8, 2022
K212005UNiD Spine AnalyzerJanuary 12, 2022
K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemJanuary 5, 2022
K210470C-CURVE Interbody Fusion DeviceSeptember 3, 2021
K200316UNiD IB3D ALIFOctober 30, 2020
K191134IB3D ALIFOctober 30, 2019
K182158UNiD Patient-matched PLIF cageJuly 15, 2019
K190092UNiD Patient specific 3D printed TLIF cageMay 8, 2019
K190376PASS LP Spinal SystemMay 2, 2019
K182240PASS LP Spinal SystemOctober 17, 2018
K173782UNiD Patient Specific 3D printed cageApril 25, 2018
K173506LigaPASSApril 3, 2018
K180091UNiD Spine AnalyzerFebruary 8, 2018
K163595IMPIX 3D Print CagesNovember 13, 2017
K172021LigaPASSAugust 30, 2017
K170172UNiD Spine AnalyzerMay 24, 2017
K162786PASS LP Spinal SystemJanuary 25, 2017
K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemDecember 8, 2016