FIRST ARTICLE INC

FDA Device Registration & Listing · Souderton, PA, US · Registration 3010032903

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
3010032903
FEI Number
3010032903
Entity Name
FIRST ARTICLE INC
City/State/Country
Souderton, PA, US
Establishment Address
150 S Front St Suite B, Souderton, PA 18964, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
First Article MFG LLC (Owner Number: 10095684)
Owner / Operator Contact Address
150 South Front Street Ste. B, Souderton, PA 18964, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TRUSS PROVIDENCE CROSSWAY PROTEX CT RISE CROSSWAY TRUSS ELLIPSE FORTIFY - Large Excelsius GPS FORTIFY - Large CONTINENTAL REVERE 5.5 Deformity Ti System CITADEL ELLIPSE ELSA REVERE 5.5 Deformity Ti System REVOLVE RELIEVE REVERE 5.5 Degen Ti System MAGNIFY REVERE 4.5 Stabilization System Excelsius GPS PROTEX CT CONTINENTAL QUARTEX LATIS PRESERVE ACDF System SILC Fixation System REVERE 5.5 Deformity Ti System SI-LOK Select ANTHEM Ti Proximal Humerus Fracture System SP-Fix COLONIAL InterContinental COALITION COLONIAL TRANSITION REVERE 5.5 Deformity Ti System ASSURE SI-LOK CREO DLX Deformity Stabilization System ELLIPSE REVERE ADDITION REVERE ADDITION INDEPENDENCE Guided Instruments REVERE 5.5 Deformity Ti System CREO 4.75mm Threaded CoCr Deformity Stabilization System InterContinental REVERE 5.5 Deformity Ti System AERIAL BEACON Posted Screw System InterContinental ASSURE-X COLONIAL PRESERVE ACDF System REVERE 6.35 Degen Ti System Excelsius GPS ASSURE SP-Fix COALITION MIS Excelsius GPS CREO AMP 5.5 Stabilization System SILC Fixation System ASSURE TRANSCONTINENTAL Excelsius GPS COALITION Excelsius GPS REVLOK QUARTEX CALIBER HAVEN UNIFY XPand InterContinental REVERE 5.5 Deformity Ti System RISE

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 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
HRX Arthroscope Orthopedic Class 2 888.1100 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
HRX Arthroscope Orthopedic Class 2 888.1100 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-04-14
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-04-14
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2026-04-14
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2026-04-14
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-04-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-04-14
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2026-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-04-14
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-04-14
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-04-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-14
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2026-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2026-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-14

Official Correspondent

Rob Simons

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

First Article MFG LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14

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-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010032903. Last updated year: 2026. Please use registration number 3010032903 when referencing this establishment in official correspondence.
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