GLOBUS MEDICAL, INC.

FDA Device Registration & Listing · AUDUBON, PA, US · Registration 3004142400

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004142400
FEI Number
3004142400
Entity Name
GLOBUS MEDICAL, INC.
City/State/Country
AUDUBON, PA, US
Establishment Address
2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER, AUDUBON, PA 19403, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GLOBUS MEDICAL, INC. (Owner Number: 9056090)
Owner / Operator Contact Address
2560 GENERAL ARMISTEAD AVE., VALLEY FORGE BUSINESS CENTER, Audubon, PA 19403, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

SmartPrep Harvest SmartPrep2 BMAC MicroFuse with Barium Sulfate REVERE ExcelsiusFlex DUAL TAPER WEDGE ANTHEM PROVIDENT CANOPY Laminoplasty Fixation System SUSTAIN RADIOLUCENT SPACER XTEND FORTIFY Corpectomy Spacer ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FORTRESS HEDRON REVLOK Fenestrated ELSA RETAIN RADIOLUCENT SPACER XPAND CORPECTOMY SPACER XPAND RADIOLUCENT CORPECTOMY ExcelsiusXR Depth Gauge For Clinical Use PROVIDENCE ANTERIOR CERVICAL PLATE GATEWAY THORACOLUMBAR PLATE SYSTEM CITADEL ANTERIO REVERE STABILIZATION SYSTEM PROVIDENT Harvest PRP CAPTIVATE PATRIOT SPACERS: COLONIAL ACDF SPAC Patriot Signature Additional PROVEN Gen-Flex REVOLVE Additional Implants ASSURE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT AFFIRM VCF SI-LOK CREO SI-LOK BEACON STABILIZATION SYSTEM REVERE STABILIZATION SYSTEM BIT, DRILL VIP ANTERIOR CERVICAL PLATE SYSTEM CONFIRM HILINE H-LINK Integrated Rod UNIFY ExcelsiusGPS PROVIDENT PROTEX CT CERVICOTHORACIC SPINAL SY REVERE STABILIZATION SYSTEM TEM PROTEX CT CERVICOTHORACIC SPINAL SYSTEM AUTOBAHN ANTHEM SECURE®-C Cervical Artificial Disc GENflex2 PROVEN Gen-Flex COALITION AGX SUSTAIN-IR ARBOR UNIFY¿ Dynamic Anterior Cervical Plate System CROSSWAY Modulus SHIELD VCF PROVEN Gen-Flex FORTIFY¿ I and FORTIFY¿ I-R Corpectomy Spacers ORTHOPEDIC MANUAL SURGICAL INSTRUMENT PATRIOT TPS Spacers FORTIFY I-R TPS Corpectomy Spacer FORTIFY-R TPS Corpectomy Spacer INDEPENDENCE TPS Spacers COALITION TPS Spacers XPand-R TPS Corpectomy Spacer NIKO TPS Corpectomy Spacer CALIBER TPS Spacers SUSTAIN R TPS Spacers Retractor Navigation Instruments ONVOY PROTRACT VERZA SP-Fix ANTHEM ACTIFY Uni PROTEX CT ELLIPSE FORTRESS-Plus TransContinental M ELLIPSE Additional Implants GENflex2 PLYMOUTH¿ Thoracolumbar Plate System CORRIDOR FIXATION SYSTEM INDEPENDENCE MIS PROGENY SUSTAIN MONUMENT INDEPENDENCE GENflex2 Harvest PRP PROVIDENT DuraPro SIGNIFY ExcelsiusGPS™ Instruments Harvest SmartCell REVERE 4.5 Stabilization System Proven Gen-Flex GENflex2 FORTIFY InstaFill QUARTEX CORBEL SCRIPT ANTHEM ZYFUSE TRUSS THORACOLUMBAR PLATE SYSTEM CREO PATRIOT TransContinenetal Lateral PATRIOT Spacers XPAND RADIOLUCENT CORPECTOMY XPAND CORPECTOMY SPACER RETAIN RADIOLUCENT SPACER XPAND RADIOLUCENT CORPECTOMY RETAIN RADIOLUCENT SPACER XPAND CORPECTOMY SPACER TEM PROTEX CT CERVICOTHORACIC SPINAL SY CITADEL ANTERIO REVERE STABILIZATION SYSTEM GATEWAY THORACOLUMBAR PLATE SYSTEM REVERE Sacral Plates PROVIDENT ELLIPSE OCCIPITO-CERVICO-THORACIC S ANTHEM NIKO Corpectomy Spacer HAVEN JOINT, KNEE, EXTERNAL BRACE Harvest PRP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT VICTORY CoCr Rods PROVEN Gen-Flex REVOLVE STABILIZATION SYSTEM MicroFuse Bone Void Filler ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ONVOY PROTEX STABILIZATION SYSTEM PROCLASS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT REVERE 6.35 STABILIZATION SYSTEM SILC PROVIDENT GENflex2 PROVEN Gen-Flex CROSSWAY COALITION® Spacer MICROFUSE BONE VOID FILLER POSTEREO SABLE HEDRON SABLE BIOLOX DELTA AERIAL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Harvest SmartPrep2 REVEL PROTEX STABILIZATION SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LATIS Spacers HEDRON SP-Fix ASSURE ANTERIOR CERVICAL PLATE SYST Harvest SmartPrep2 ANTHEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT STRETTO MicroFuse Putty & MIS Harvest CREO Stabilization System SCRIPT CITADEL ANTERIOR LUMBAR PLATE SYSTEM Bone Cement TRANSCONTINENTAL INTERCONTINENTAL PROTRACT COALITION KINEX CORRIDOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ACTIFY 3D Harvest Adiprep PROFORM RELIEVE LAMINOPLASTY FIXATION SYSTE BEACON Stabilization System PROVIDENT Harvest SmartPrep COALITION SPACER RISE¿ Spacer PROVEN Gen-Flex Navigation Instruments MAGNIFY Spacers MARVEL INDEPENDENCE SPACER ExcelsiusGPS QUARTEX RIB LINK REVERE CROSSTOP CALIBER RESONATE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL ALTERA TRANSITION STABILIZATION SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT PROVIDENT REFLECT Capitol - Ellipse Additional SUSTAIN COLONIAL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-02-12
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-16
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2023-05-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-07-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-07-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-07-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-07-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-07-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-30
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-06-13
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2023-06-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-03
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-02-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-03
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-06-13
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2023-06-13
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-06-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-06-13
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2023-06-13
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-06-13
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2023-06-13
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2023-06-13
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2012-11-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-12-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-01-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-01-20
HWA Impactor Orthopedic Class 1 888.4540 2024-08-23
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2013-04-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-12-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-01-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-10-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-10-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2003-08-19
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2025-07-10
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2024-08-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-12-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2004-11-03
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2023-06-13
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2023-05-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2008-12-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-04-29
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2023-06-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-08-29
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2024-04-01
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2012-01-20
HRX Arthroscope Orthopedic Class 2 888.1100 2012-01-20
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2019-03-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-03-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-09
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-04-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-04-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-04-09
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2012-01-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-04
HTW Bit, Drill Orthopedic Class 1 888.4540 2015-05-28
NQO Prosthesis, Spinous Process Spacer/Plate Unknown Class 3 N/A 2014-02-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-12-15
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-01-28
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2023-04-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-02-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-01-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-30
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-06-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2004-11-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2004-11-03
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2026-04-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-04-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-04-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-11-10
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2012-11-26
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-09-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-09-22
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-09-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-04-07
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2018-03-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-03-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-26
HRX Arthroscope Orthopedic Class 2 888.1100 2018-09-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-29
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2012-11-26
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-11-26
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2024-08-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-04-25
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-04-25
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-04-25
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-04-25
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-04-25
GAD Retractor General, Plastic Surgery Class 1 878.4800 2015-05-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-06-26
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2022-11-18
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-11-18
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2022-11-18
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-06-30
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-02-20
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2015-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-11-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-11-07
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2024-12-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-09-22
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2015-09-22
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-02-12
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-06-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-26
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2009-12-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-09-23
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2023-06-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-12-15
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-01-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2018-08-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-08-03
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-06-13
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2023-05-16
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-06-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-05-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-01-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-11-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-11-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-11-14
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2023-05-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-11-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-11-14
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-04-14
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2018-11-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-11-14
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2014-02-12
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-08-22
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2022-08-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-09-28
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-09-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-09-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-08-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2020-08-07
PGM Growing Rod System Orthopedic Class 2 888.3070 2026-05-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-05-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-05-11
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-05-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-08-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-08-07
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-01-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-01-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2008-02-26
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2003-08-19
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2003-08-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2007-01-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-01-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2007-01-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2007-01-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2007-01-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-01-20
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2014-02-12
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-06-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-26
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2017-07-24
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2024-11-12
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-05-16
HWB Extractor Orthopedic Class 1 888.4540 2024-08-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-11-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-01-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2009-12-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-12-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-12-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-12-18
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2014-02-12
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-02-26
HTO Reamer Orthopedic Class 1 888.4540 2024-08-23
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2025-06-18
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-06-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-06-18
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-06-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-12-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-12-15
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2008-12-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-12-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-12-15
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-06-13
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-06-13
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2024-04-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-12-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-12-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-12-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2009-12-18
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2019-02-06
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-06-13
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
HRX Arthroscope Orthopedic Class 2 888.1100 2019-04-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-08-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-12-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-11-28
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2022-11-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-11-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-11-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-11-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-14
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2022-12-19
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2022-12-19
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2022-12-19
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2022-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-12-19
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2022-12-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-12-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-12-19
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2018-06-26
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2014-02-12
LYS Bone Mill Orthopedic Class 1 888.4540 2024-08-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-16
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2023-05-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-01-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-01-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-12-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-12-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-12-22
HXX Screwdriver Orthopedic Class 1 888.4540 2024-08-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-08-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-25
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2019-09-25
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-09-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-12-15
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2023-05-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-06
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-04-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-08-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-08-09
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2023-08-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2012-01-20
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-08-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-08-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-08-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-08-26
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-08-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-08-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-30
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2026-04-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-30
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2026-04-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2004-11-03
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2012-11-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-05-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-05-24
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-06-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-02-12
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-05-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-05-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-05-10
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-13
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2020-01-13
HTQ Broach Orthopedic Class 1 888.4540 2024-08-23
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2024-07-11
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2024-07-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-07-11
QKL Lipoaspirate Washing System For Aesthetic Body Contouring General, Plastic Surgery Class 2 878.5040 2023-05-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-06-13
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2008-12-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-02-26
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-06-13
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2023-05-16
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2009-12-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-11-26
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-06-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-03-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-09-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-09-22
PGM Growing Rod System Orthopedic Class 2 888.3070 2023-01-05
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2008-12-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-04-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2024-04-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-01-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-10-25
JEB Table, Surgical With Orthopedic Accessories, Manual General, Plastic Surgery Class 1 878.4950 2025-04-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-01-28
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2009-12-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-02-12
HXC Wrench Orthopedic Class 1 888.4540 2024-08-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-06-13
QHP Vertebral Body Tethering System Unknown Class N N/A 2023-05-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-06-26

Official Correspondent

DANIEL PAUL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GLOBUS MEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3000779542 Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts San Antonio, TX, US
3011713200 GLOBUS MEDICAL, INC. Methuen, MA, US
3030412764 GLOBUS MEDICAL, INC. Memphis, TN, US
3013491327 NML Medical, LLC West Carrollton, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number Establishment Name Location
3009941480 LISI MEDICAL REmmele Big Lake, MN, US
3004635447 C&W SWISS, INC. CLAYTON, OH, US
3015869493 Jabil Switzerland Manufacturing GmbH (Mezzovico) Mezzovico Ticino, CH
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
3009417901 SYNTHES GMBH Zuchwil Solothurn, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004142400. Last updated year: 2026. Please use registration number 3004142400 when referencing this establishment in official correspondence.
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