SECURE-C CERVICAL ARTIFICIAL DISC
GLOBUS MEDICAL INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004142400 | 3004142400 | GLOBUS MEDICAL, INC. | 1 | N | 2026-01-01 | 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER AUDUBON PA US 19403 |
| 3011713200 | 3011713200 | GLOBUS MEDICAL, INC. | 1 | N | 2026-01-01 | 300 GRIFFIN BROOK DRIVE Methuen MA US 01844 |
| 3030412764 | 3030412764 | GLOBUS MEDICAL, INC. | 1 | N | 2026-01-01 | 4670 E. SHELBY DR Memphis TN US 38118 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00849044040517 | N/A - Fiber-Optic Cord | +1(610)930-1800 | info@globusmedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 325575 | 1205369161 | P200022 | Simplify® Cervical Artificial Disc | MJO | 2020-09-18 |
| 325575 | 1559103463 | P100012 | NUVASIVE PCM CERVICAL DISC SYSTEM | MJO | 2012-10-26 |
| 61785 | 1658846134 | P100003 | SECURE-C ARTIFICIAL CERVICAL DISC | MJO | 2012-09-28 |
| 325575 | 1658846134 | P100003 | SECURE-C ARTIFICIAL CERVICAL DISC | MJO | 2012-09-28 |
| 61785 | 1391000222 | K991430 | SMARTPREP CENTRIFUGE SYSTEM | JQC | 1999-05-28 |
| 61785 | 1152609507 | K983022 | SMARTCELL PROCESSING SYSTEM | CAC | 1999-04-02 |
| 61785 | 1624934350 | K981451 | ARGOMEDICAL BIPOLAR SYSTEM | KWL | 1998-08-21 |
| 325575 | 1624934350 | K981451 | ARGOMEDICAL BIPOLAR SYSTEM | KWL | 1998-08-21 |
| 61785 | 1643788679 | K980276 | STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM | JWH | 1998-04-24 |
| 325575 | 1643788679 | K980276 | STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM | JWH | 1998-04-24 |
| 61785 | 1561001422 | K960180 | 22 MM COCR HEAD & POLYETHLENE LINER | LPH | 1996-05-02 |
| 61785 | 1504970899 | K953268 | DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT | LWJ | 1996-01-17 |
| 325575 | 1504970899 | K953268 | DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT | LWJ | 1996-01-17 |
| 61785 | 2050547746 | K952461 | ENDO PROSTHESIS FEMORAL HEAD | JDI | 1995-06-30 |
| 325575 | 2050547746 | K952461 | ENDO PROSTHESIS FEMORAL HEAD | JDI | 1995-06-30 |
| 61785 | 1461270115 | K950827 | PROFORM POROUS ACETABULAR ASSEMBLY | LPH | 1995-04-18 |
| 61785 | 1741850782 | K935484 | PROVIDENT HIP SYSTEM | LPH | 1994-06-06 |
| 325575 | 1741850782 | K935484 | PROVIDENT HIP SYSTEM | LPH | 1994-06-06 |
| 61785 | 1033867230 | K934162 | PROFORM HA HIP SYSTEM | JDO | 1994-03-09 |
| 325575 | 1568992895 | K811820 | BIPOLAR COAGULATING FORCEPS | GEI | 1981-07-28 |
| 61785 | 1186822758 | K261043 | AUTOBAHN™ Nailing System | HSB | 2026-04-24 |
| 325575 | 1186822758 | K261043 | AUTOBAHN™ Nailing System | HSB | 2026-04-24 |
| 61785 | 1841787766 | K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | OVE | 2025-12-22 |
| 61785 | 1713536853 | K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System | NKB | 2026-05-07 |
| 61785 | 1316636681 | K253401 | SCRIPT™ Implant System | OVD | 2026-04-29 |
| 61785 | 1111743214 | K252166 | RIB LINK™ Fixation System | HRS | 2026-02-26 |
| 325575 | 1111743214 | K252166 | RIB LINK™ Fixation System | HRS | 2026-02-26 |
| 61785 | 1272368081 | K251161 | ANTHEM® Fracture System | HRS | 2025-08-18 |
| 325575 | 1272368081 | K251161 | ANTHEM® Fracture System | HRS | 2025-08-18 |
| 61785 | 1532323018 | K250599 | ExcelsiusGPS™ Instruments | OLO | 2025-11-05 |
| 61785 | 1752734890 | K243671 | ExcelsiusGPS® Instruments | OLO | 2024-12-20 |
| 61785 | 1729916422 | K243456 | ONVOY™ Acetabular System | LPH | 2025-06-06 |
| 325575 | 1729916422 | K243456 | ONVOY™ Acetabular System | LPH | 2025-06-06 |
| 61785 | 1437824298 | K241525 | ExcelsiusXR™ | SBF | 2025-07-08 |
| 61785 | 1064389716 | K241260 | ACTIFY™ Unicondylar Knee System | HSX | 2024-12-06 |
| 325575 | 1064389716 | K241260 | ACTIFY™ Unicondylar Knee System | HSX | 2024-12-06 |
| 61785 | 2062738251 | K240947 | TENSOR® Suture Button System | HTN | 2024-06-03 |
| 325575 | 2062738251 | K240947 | TENSOR® Suture Button System | HTN | 2024-06-03 |
| 61785 | 1453911727 | K240721 | ExcelsiusFlex™ | OLO | 2024-06-14 |
| 61785 | 1457899783 | K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | JWH | 2024-06-20 |
| 325575 | 1457899783 | K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | JWH | 2024-06-20 |
| 61785 | 1290733604 | K240568 | DuraPro™ Oscillating System | OLO | 2024-04-29 |
| 325575 | 1290733604 | K240568 | DuraPro™ Oscillating System | OLO | 2024-04-29 |
| 61785 | 1184881261 | K234035 | COSINE™ Spacer | MAX | 2024-09-06 |
| 61785 | 1438168747 | K233735 | ADIRA™ Lateral Plate System | KWQ | 2024-01-25 |
| 61785 | 2003143273 | K233638 | VERZA™ High Speed Drills | OLO | 2024-02-09 |
| 325575 | 2003143273 | K233638 | VERZA™ High Speed Drills | OLO | 2024-02-09 |
| 61785 | 1204133542 | K232318 | VICTORY™ Lumbar Plate System | KWQ | 2023-10-31 |
| 61785 | 1151892098 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | NKG | 2024-03-14 |
| 325575 | 1510781060 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | ODP | 2023-07-11 |
| 61785 | 1822801176 | K231333 | STRETTO™ Cable System | JDQ | 2023-08-04 |
| 325575 | 1822801176 | K231333 | STRETTO™ Cable System | JDQ | 2023-08-04 |
| 325575 | 1975564325 | K230989 | Rod Registration Frame | OLO | 2023-05-05 |
| 325575 | 1843521862 | K230894 | NuVasive Modulus ALIF System | OVD | 2023-06-16 |
| 61785 | 2052865016 | K230565 | HILINE™ Fixation System | OWI | 2023-04-20 |
| 61785 | 1731740277 | K223731 | NuVasive Modulus-C Interbody System | ODP | 2023-01-12 |
| 325575 | 1620907754 | K223181 | NuVasive Reline System | NKB | 2023-01-11 |
| 61785 | 1525053270 | K222409 | CAPTIVATE® Compression Screws | HWC | 2022-09-08 |
| 61785 | 1955964027 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments | ODP | 2022-10-21 |
| 325575 | 1577690921 | K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | OVD | 2022-10-21 |
| 61785 | 1204600564 | K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | FMF | 2022-08-11 |
| 325575 | 1204600564 | K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | FMF | 2022-08-11 |
| 325575 | 1056323552 | K221388 | NuVasive Reline Cervical System | NKG | 2022-09-09 |
| 61785 | 1487615088 | K220659 | AUTOBAHN(R) EVO Femoral Nails | HSB | 2022-09-09 |
| 325575 | 1487615088 | K220659 | AUTOBAHN(R) EVO Femoral Nails | HSB | 2022-09-09 |
| 325575 | 1892390597 | K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | MAX | 2022-06-21 |
| 61785 | 1442214457 | K213842 | ONVOY Acetabular System | LPH | 2022-10-03 |
| 325575 | 1289820108 | K213654 | NuVasive Reline Cervical System | NKG | 2022-02-23 |
| 61785 | 1298049539 | K213591 | ANTHEM® Fracture System | HRS | 2022-01-26 |
| 61785 | 1567703064 | K213196 | MARVEL™ Growing Rods | PGM | 2022-12-19 |
| 325575 | 1771958029 | K212446 | NuVasive Anterior Cervical Plate Systems | KWQ | 2021-11-03 |
| 61785 | 1653772409 | K212433 | Anthem Fracture System | HRS | 2021-10-01 |
| 61785 | 1036159581 | K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | NKG | 2021-08-18 |
| 325575 | 1731552755 | K211757 | Simplify Disc | QLQ | 2021-08-20 |
| 210486 | 1931020516 | K211616 | ExcelsiusHub | OLO | 2021-08-25 |
| 210486 | 1317127324 | K210912 | Excelsius3D | OWB | 2021-08-12 |
| 325575 | 1587854361 | K210574 | NuVasive Pulse System | OLO | 2021-07-29 |
| 325575 | 1184189148 | K210439 | NuVasive MOD-EX XLIF Interbody System | MAX | 2021-05-12 |
| 325575 | 1599314605 | K210271 | NuVasive Modulus ALIF System | OVD | 2021-03-01 |
| 325575 | 1465371741 | K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | MAX | 2021-05-24 |
| 325575 | 1527785923 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | MAX | 2021-12-23 |
| 325575 | 1590865072 | K203253 | NuVasive ACP System | KWQ | 2020-12-03 |
| 325575 | 1236998366 | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System | MAX | 2021-01-12 |
| 61785 | 1243580998 | K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | NKB | 2021-01-19 |
| 61785 | 1683374155 | K202496 | ANTHEM Fracture System | HRS | 2020-10-29 |
| 325575 | 1973168318 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System | MAX | 2020-09-25 |
| 325575 | 1616913848 | K201692 | NuVasive Modulus XLIF Interbody System | MAX | 2020-10-29 |
| 61785 | 1561609796 | K201087 | CORBEL Spacers | OVD | 2020-07-31 |
| 325575 | 1561609796 | K201087 | CORBEL Spacers | OVD | 2020-07-31 |
| 325575 | 1026186822 | K201078 | NuVasive® ACP System | KWQ | 2020-05-20 |
| 325575 | 1433471125 | K200956 | NuVasive Thoracolumbar Plates | KWQ | 2020-05-21 |
| 325575 | 1934248934 | K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | MAX | 2020-10-06 |
| 325575 | 1774327796 | K200719 | NuVasive Navigation.S Instruments | OLO | 2020-12-02 |
| 210486 | 1245474177 | K200047 | ExcelsiusGPS Cranial 1.0 Module | OLO | 2020-07-10 |
| 325575 | 1524096983 | K193593 | NuVasive 3DP Interfixated ALIF System | OVD | 2020-03-25 |
| 325575 | 2049482876 | K193541 | NuVasive Cohere Thoracolumbar Interbody System | MAX | 2020-03-30 |
| 325575 | 1150956686 | K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | MQP | 2020-02-26 |
| 325575 | 1053805996 | K192760 | NuVasive Modulus XLIF Interbody System | MAX | 2019-10-18 |
| 61785 | 1404413264 | K192744 | CORRIDOR Fixation System | MRW | 2019-12-16 |
| 325575 | 1074466318 | K192582 | NuVasive CoRoent Small Interlock System | OVE | 2019-11-13 |
| 325575 | 1952568851 | K192435 | NuVasive NuvaLine | LLZ | 2019-09-26 |
| 61785 | 1243739197 | K192314 | RESONATE Anterior Cervical Plate System | KWQ | 2019-10-23 |
| 61785 | 1596225161 | K192115 | SABLE Expandable Spacer | MAX | 2020-01-14 |
| 325575 | 1596225161 | K192115 | SABLE Expandable Spacer | MAX | 2020-01-14 |
| 61785 | 1371158577 | K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | NKB | 2019-08-06 |
| 325575 | 1187084923 | K191553 | NuVaisve® Reline® Cervical System | NKG | 2019-08-14 |
| 325575 | 1034375450 | K191500 | NuVasive® ACP System | KWQ | 2019-09-03 |
| 61785 | 1363044847 | K191391 | HEDRON Lumbar Spacers | MAX | 2019-09-18 |
| 325575 | 1363044847 | K191391 | HEDRON Lumbar Spacers | MAX | 2019-09-18 |
| 61785 | 1738922246 | K191243 | HEDRON Cervical Spacers | ODP | 2019-09-17 |
| 325575 | 1913556536 | K191169 | NuVasive® Camber Laminoplasty System | NQW | 2019-07-03 |
| 210486 | 1551005347 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | OLO | 2019-07-24 |
| 61785 | 1769698510 | K190653 | ExcelsiusGPS | OLO | 2019-04-09 |
| 325575 | 1812720286 | K190636 | NuVasive® Reline® 4.5-5.0 System | NKB | 2019-10-19 |
| 61785 | 1540244859 | K190598 | CROSSWAY Spinal Access System | HRX | 2019-04-05 |
| 325575 | 1711271408 | K190418 | NuVasive® VersaTie® System | OWI | 2019-03-21 |
| 61785 | 1864911531 | K190276 | Provident II Hip Stem | LPH | 2019-03-08 |
| 61785 | 1288533248 | K190147 | COLOSSEUM Mesh | MQP | 2019-05-08 |
| 61785 | 1950475623 | K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments | OUR | 2019-02-06 |
| 325575 | 1950475623 | K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments | OUR | 2019-02-06 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MAX | 60 | 2024-09-06 |
| NKB | 44 | 2026-05-07 |
| KWQ | 41 | 2024-01-25 |
| OVD | 29 | 2026-04-29 |
| MQP | 25 | 2020-02-26 |
| OLO | 21 | 2025-11-05 |
| JWH | 21 | 2024-06-20 |
| ODP | 19 | 2023-07-11 |
| MQV | 12 | 2015-10-08 |
| HRS | 11 | 2026-02-26 |
| NKG | 11 | 2024-03-14 |
| LPH | 10 | 2025-06-06 |
| OVE | 9 | 2025-12-22 |
| KWP | 9 | 2013-03-14 |
| LWJ | 8 | 2003-09-22 |
| OWI | 7 | 2023-04-20 |
| PDQ | 7 | 2017-03-16 |
| NDN | 7 | 2017-01-23 |
| ETN | 7 | 2012-04-13 |
| HSB | 6 | 2026-04-24 |
| OWB | 6 | 2021-08-12 |
| MRW | 6 | 2019-12-16 |
| PEK | 6 | 2018-05-21 |
| FMF | 5 | 2022-08-11 |
| NQW | 5 | 2019-07-03 |
| MNH | 5 | 2006-09-01 |
| HSX | 4 | 2024-12-06 |
| HWC | 4 | 2022-09-08 |
| OQG | 4 | 2012-10-09 |
| GWF | 4 | 2010-05-14 |
| MJO | 3 | 2020-09-18 |
| LLZ | 3 | 2019-09-26 |
| JQC | 3 | 2010-12-06 |
| HTN | 2 | 2024-06-03 |
| JDQ | 2 | 2023-08-04 |
| PGM | 2 | 2022-12-19 |
| HRX | 2 | 2019-04-05 |
| OUR | 2 | 2019-02-06 |
| PML | 2 | 2018-11-28 |
| PLR | 2 | 2018-11-20 |
GLOBUS MEDICAL INC.
GLOBUS MEDICAL INC.
GLOBUS MEDICAL INC.
GLOBUS MEDICAL INC.
GLOBUS MEDICAL INC.
GLOBUS MEDICAL INC.
GLOBUS MEDICAL INC.
Globus Medical, Inc.
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