Company · FR
Medicrea International
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2022. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
22recalls (2 in 12 months)
17recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 14 |
| NKB | Thoracolumbosacral Pedicle Screw System | 11 |
| OWI | Bone Fixation Cerclage, Sublaminar | 6 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 |
| NKG | Posterior Cervical Screw System | 5 |
| LLZ | System, Image Processing, Radiological | 4 |
| MNI | Orthosis, Spinal Pedicle Fixation | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 |
| JDQ | Cerclage, Fixation | 1 |
| MJO | Prosthesis, Intervertebral Disc | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
| PHQ | Anterior Staple As Supplemental Fixation For Fusion | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2022 | K213659 | LigaPASS 2.0 Ligament Augmentation System Medicrea International SA, FR | OWI |
| Apr 19, 2022 | K220810 | Infinity OCT System and PASS OCT Spinal System Medicrea International, FR | NKG |
| Apr 8, 2022 | K220724 | CD Horizon Spinal System and PASS LP Spinal System Medicrea International, FR | NKB |
| Jan 12, 2022 | K212005 | UNiD Spine Analyzer Medicrea International, Inc., FR | LLZ |
| Jan 5, 2022 | K213281 | PASS LP Spinal System, CD Horizon Spinal System Medicrea International SA, FR | NKB |
| Sep 3, 2021 | K210470 | C-CURVE Interbody Fusion Device Medicrea International SA, FR | OVE |
| Oct 30, 2020 | K200316 | UNiD IB3D ALIF Medicrea International SA, FR | MAX |
| Oct 30, 2019 | K191134 | IB3D ALIF Medicrea International SA, FR | MAX |
| Jul 15, 2019 | K182158 | UNiD Patient-matched PLIF cage Medicrea International SA, FR | MAX |
| May 8, 2019 | K190092 | UNiD Patient specific 3D printed TLIF cage Medicrea International SA, FR | MAX |
| May 2, 2019 | K190376 | PASS LP Spinal System Medicrea International SA, FR | NKB |
| Oct 17, 2018 | K182240 | PASS LP Spinal System Medicrea International SA, FR | NKB |
| Apr 25, 2018 | K173782 | UNiD Patient Specific 3D printed cage Medicrea International SA, FR | MAX |
| Apr 3, 2018 | K173506 | LigaPASS Medicrea International SA, FR | OWI |
| Feb 8, 2018 | K180091 | UNiD Spine Analyzer Medicrea International, FR | LLZ |
| Nov 13, 2017 | K163595 | IMPIX 3D Print Cages Medicrea International SA, FR | MAX |
| Aug 30, 2017 | K172021 | LigaPASS Medicrea International SA, FR | OWI |
| May 24, 2017 | K170172 | UNiD Spine Analyzer Medicrea International, FR | LLZ |
| Jan 25, 2017 | K162786 | PASS LP Spinal System Medicrea International SA, FR | NKB |
| Dec 8, 2016 | K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System Medicrea International SA, FR | KWQ |
| Sep 23, 2016 | K160640 | PASS XS Spinal System Medicrea International SA, FR | NKB |
| Sep 2, 2016 | K160698 | LigaPASS Medicrea International SA, FR | OWI |
| Jul 29, 2016 | K161627 | PASS LP Spinal System Medicrea International SA, FR | NKB |
| Jul 11, 2016 | K161149 | PASS OCT Spinal System Medicrea International SA, FR | NKG |
| Apr 26, 2016 | K160756 | PASS OCT Spinal System Medicrea International SA, FR | NKG |
| Apr 22, 2016 | K153413 | PASS LP Spinal System Medicrea International SA, FR | NKB |
| Jan 29, 2016 | K153169 | PASS OCT Patient Specific Rods Medicrea International, FR | NKG |
| Oct 16, 2015 | K150918 | PASS OCT Spinal System Medicrea International SA, FR | NKG |
| Mar 25, 2015 | K142798 | PASS LP Spinal System Medicrea International SA, FR | MNH |
| Feb 10, 2015 | K150049 | PASS LP Spinal System Medicrea International, FR | MNI |
| Jan 15, 2015 | K141187 | IMPIX ALIF S/A Medicrea International SA, FR | OVD |
| Jan 9, 2015 | K141398 | PASS LP SPINAL SYSTEM Medicrea International SA, FR | NKB |
| Nov 4, 2014 | K140738 | PASS LP SPINAL SYSTEM Medicrea International, FR | MNI |
| Jul 24, 2014 | K133906 | C-JAWS CERVICAL COMPRESSIVE STAPLE Medicrea International | PHQ |
| Dec 6, 2013 | K132395 | LIGAPASS Medicrea International, FR | OWI |
| Nov 8, 2013 | K132574 | PASS LP SPINAL SYSTEM Medicrea International, FR | OSH |
| Oct 3, 2013 | K132575 | PASS LP SPINAL SYSTEM Medicrea International, FR | OSH |
| Mar 21, 2013 | K121979 | PASS OCT SPINAL SYSTEM Medicrea International, FR | KWP |
| Feb 5, 2013 | K123138 | PASS LP SPINAL SYSTEM Medicrea International, FR | OSH |
| Jul 18, 2012 | K121323 | MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE Medicrea International, FR | KWQ |
| Feb 1, 2012 | K112736 | PASS LP SPINAL Medicrea International | JDQ |
| Nov 21, 2011 | K112493 | PASS LP SPINAL SYSTEM Medicrea International | MNI |
| Sep 26, 2011 | K110497 | PASS LP SPINAL SYSTEM Medicrea International | MNH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | Medicrea International Medicrea, IB3D PL Instruments Set, Rx Only
REF: SPS03174 Open, Classified |
MAX | K241164 |
| Jan 9, 2026 | Medicrea International Medicrea, IB3D Universal Implant Inserter, Rx Only
REF: A24000000 Open, Classified |
MAX | K241164 |
| Feb 7, 2025 | Medicrea International UNiD" Adaptive Spine Intelligence
UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929
Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD H Open, Classified |
LLZ | K212005 |
| Aug 24, 2023 | Medicrea International IMPIX MANTA+, REF numbers:
a) B20171743,
b) B20171753,
c) B20171763,
d) B20171773,
e) B20171943,
f) B20171953,
g) B20171963,
h) B20171973,
i) B20172253,
j) B20172263,
k) B20172273; interve Open, Classified |
ODP | None listed |
| Aug 24, 2023 | Medicrea International IMPIX S, REF numbers:
a) B15328071S,
b) B15328073S,
c) B15328074S,
d) B15334072S,
e) B15334073S,
f) B15334074S; intervertebral fusion device - cervical Open, Classified |
MAX | None listed |
| Aug 24, 2023 | Medicrea International IMPIX C+, REF numbers:
a) B20240104,
b) B20240105,
c) B20240106,
d) B20240107,
e) B20240205,
f) B20240206,
g) B20240207,
h) B20240208; intervertebral fusion device - cervical Open, Classified |
ODP | None listed |
| Aug 24, 2023 | Medicrea International GRANVIA-C, REF numbers:
a) A13111427,
b) A13112567,
c) A13113456,
d) A13131516,
e) A13131789,
f) A13132012,
g) B13111014,
h) B13111015,
i) B13111016,
j) B13111017,
k) B13111025,
l) B13111 Open, Classified |
MJO | None listed |
| Aug 24, 2023 | Medicrea International PASS LP, REF numbers:
a) B02315535Z,
b) B02315540Z,
c) B02315545Z,
d) B02315550Z,
e) B02316535Z,
f) B02316540Z,
g) B02316545Z,
h) B02316550Z,
i) B02317540Z,
j) B02317545Z,
k) B02317550Z; i Open, Classified |
MNI | K110497 |
| Aug 24, 2023 | Medicrea International IMPIX TLIF, REF numbers:
a) B15130607S,
b) B15130609S,
c) B15130611S,
d) B15130613S,
e) B15130615S,
f) B15900806,
g) B15900906,
h) B15901006,
i) B15901106,
j) B15901206,
k) B15901306; inte Open, Classified |
MAX | K083798 |
| Aug 24, 2023 | Medicrea International IMPIX MANTA, REF numbers:
a) A20150407,
b) A20250407,
c) A20350567,
d) B20181743,
e) B20181753,
f) B20181763,
g) B20181773,
h) B20181943,
i) B20181953,
j) B20181963,
k) B20181973,
l) B201 Open, Classified |
ODP | K100484 |
| Aug 24, 2023 | Medicrea International IMPIX DLIF, REF numbers:
a) B16123509,
b) B16123511,
c) B16124009,
d) B16124013,
e) B16124509,
f) B16124511,
g) B16124513,
h) B16164009,
i) B16164013,
j) B16165009,
k) B16165013; interver Open, Classified |
MAX | K100544 |
| Aug 24, 2023 | Medicrea International IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar Open, Classified |
OVD | K141187 |
| Aug 24, 2023 | Medicrea International IMPIX ALIF, REF numbers:
a) B15111209,
b) B15111212,
c) B15111409,
d) B15111412; intervertebral fusion device - lumbar Open, Classified |
MAX | K083798 |
| Aug 24, 2023 | Medicrea International IMPIX 3D, REF numbers:
a) B242C09122810,
b) B242C10062810,
c) B242C10122810,
d) B242C11062810,
e) B242C11122810,
f) B242C12062810,
g) B242C12122810,
h) B242C12123310,
i) B242C13062810,
j) Open, Classified |
MAX | K163595 |
| Oct 8, 2020 | Medicrea International MEDICREA LIGAPASS TENSION PULLEY HANDLE XS-
intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies
Ref : A08200200 Terminated |
OWI | None listed |
| Jan 28, 2020 | Medicrea International Iliac Screws, multiple sizes,
Article Nos. B36020500
B36020570
B36020580
B36020590
B36027500
B36027570
B36027580
B36027590
B36028500
B36028570
B36028580
B36028590
B36029500
B36029570
B36029580
B36029 Terminated |
KWP | K190376 |
| Jan 28, 2020 | Medicrea International Pedicle Screws, multiple sizes,
Article Nos. B36004525
B36004530
B36004535
B36004540
B36004545
B36004550
B36004555
B36005530
B36005535
B36005540
B36005545
B36005550
B36005555
B36005560
B36006530
B360 Terminated |
KWP | K190376 |
| Nov 11, 2019 | Medicrea International Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System
Ref : A22020500 Terminated |
NKB | K190376 |
| Oct 2, 2019 | Medicrea International Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device
Catalog: Number A24200010 Terminated |
MAX | K163595 |
| Sep 16, 2019 | Medicrea International Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol
Product reference: A06010140 Open, Classified |
KWP | K190376 |
| Sep 16, 2019 | Medicrea International Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol
Product reference : A06010130 Open, Classified |
KWP | K190376 |
| Jun 27, 2019 | Medicrea International Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO Terminated |
NKB | K141398 |