NML Medical, LLC

FDA Device Registration & Listing · West Carrollton, OH, US · Registration 3013491327

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
3013491327
FEI Number
3013491327
Entity Name
NML Medical, LLC
City/State/Country
West Carrollton, OH, US
Establishment Address
805 Liberty Lane, West Carrollton, OH 45449, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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
N/A
PMA Number
N/A

All Registered Proprietary Names

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Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-29
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-29
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-01-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-24
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-01-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-26
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-01-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-24
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-29
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2024-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-01-24
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-23
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-26
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-26
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-12-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-12-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-12-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-26
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-24
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-24
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-24
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-01-23
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-23
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-01-26
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2024-01-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-26
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-23
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-29
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2024-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-29
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-23
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2024-01-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-26
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-01-24
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-24
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2024-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-26
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-26
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-23
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-01-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-01-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-24
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-24

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
3004142400 GLOBUS MEDICAL, INC. AUDUBON, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013491327. Last updated year: 2026. Please use registration number 3013491327 when referencing this establishment in official correspondence.
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