B & G MFG. CO.

FDA Device Registration & Listing · HATFIELD, PA, US · Registration 3004188066

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
3004188066
FEI Number
3004188066
Entity Name
B & G MFG. CO.
City/State/Country
HATFIELD, PA, US
Establishment Address
3067 UNIONVILLE PIKE, HATFIELD, PA 19440, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
B&G Manufacturing Company (Owner Number: 9058527)
Owner / Operator Contact Address
3067 UNIONVILLE PIKE, --, Hatfield, PA 19440, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ODP - Intervertebral fusion device with bone graft, cervical COALITION MIS Intervertebral fusion device UNIFY TM Dynamic Anterior Cervical Plate System Intervertebral fusion device CREO Stabilization System Line Extension to: Stalif M Stalif M-Ti

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-01-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-01-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-12-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-12-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-12-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-12-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-12-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
PGM Growing Rod System Orthopedic Class 2 888.3070 2023-03-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-03-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-07
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-07
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-04-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2022-01-05
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2022-01-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-03-27
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2023-03-27
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-01-05
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-11-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-04-15
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-03-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-03-27
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-01-05
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-27
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-12-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-04-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-04-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-04-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-04-13
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-04-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-12-23
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2020-12-23
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-03-27
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-01-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-27
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2018-12-27
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-12-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-12-27
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2023-03-27
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-03-27
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2023-03-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2013-04-15
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2013-04-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-03-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-03-27
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-12
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2019-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-12
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-04-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-01-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-12-28
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-12-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-03-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-03-30
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-03-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-11-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-05
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-01-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-30
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-03-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-04-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-04-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-01-05
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-01-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-05
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-01-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-05
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-02-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-02-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-02-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-02-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-02-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-02-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-15

Official Correspondent

Scott Reiff

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

B&G Manufacturing Company
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
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
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
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004188066. Last updated year: 2026. Please use registration number 3004188066 when referencing this establishment in official correspondence.
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