BRANCH MEDICAL GROUP

FDA Device Registration & Listing · Limerick, PA, US · Registration 3019767615

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
3019767615
FEI Number
3019767615
Entity Name
BRANCH MEDICAL GROUP
City/State/Country
Limerick, PA, US
Establishment Address
475 North Lewis Road, Limerick, PA 19468, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Branch Medical Group (Owner Number: 10043278)
Owner / Operator Contact Address
1111 Adams Avenue, Eagleville, PA 19403, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-03-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-18
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-03-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-03-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-07-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-07-08
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2021-07-08
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-01-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-02-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-07-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-07-08
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-07-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-03-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-03-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-01-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-01-19
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-01-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-17
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2013-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-02-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-03-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-03-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-07-08
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2021-07-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-11-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-07-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-07-08
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-07-08
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-07-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-08
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2013-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-08
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2024-01-24
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-01-24
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-03-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-03-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-02-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2014-01-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-02-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-07-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-07-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-07-08
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2021-07-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-07-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-07-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-11-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-11-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-08
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-07-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-07-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-02-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-02-08
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2013-02-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-18
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-03-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-07-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-07-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-01-20
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-07-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-07-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-03-17
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-03-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-03-17

Official Correspondent

Daniel Paul

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Branch Medical Group
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010120104 BRANCH MEDICAL GROUP Eagleville, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K192492 Astura Medical, LLC EL CAPITAN Anterior Lumber Interbody System 2020-04-21
K212498 Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System 2022-03-18
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30

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 3019767615. Last updated year: 2026. Please use registration number 3019767615 when referencing this establishment in official correspondence.
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