B & J Medical LLC

FDA Device Registration & Listing · Kendallville, IN, US · Registration 3009973699

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
3009973699
FEI Number
3009973699
Entity Name
B & J Medical LLC
City/State/Country
Kendallville, IN, US
Establishment Address
4268 East US Hwy 6, Kendallville, IN 46755, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
B&J Medical (Owner Number: 10042587)
Owner / Operator Contact Address
4268 East U.S. Hwy 6, Kendallville, IN 46755, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LOCKING PROXIMAL FERMUR PLATE RESPONSE SPINAL SYSTEM AO 4MM CANNULATED DRILL PediPlates Band-Loc PEDLIOC Delta Plates RESPONSE Spine System Orthopedicatrics Cannulated Bone Screws Orthopediactrics B&J Medical Orthopediactrics B&J Medical Orthopedicatrics B&J Medical Response 5.5/6 Spine System Locking Cannulated Blade Plate System B&J Medical B&J Medical

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-06-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-11-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-06-18
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-06-18
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-09-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-11-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-11-20
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-11-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-11-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-11-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-11-20
HTW Bit, Drill Orthopedic Class 1 888.4540 2023-06-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-10-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-10-26
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2023-07-25
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2016-08-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-10-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-10-26
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-01-28
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-24
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-06-24
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-11-20
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-11-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-11-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-01-13
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2024-06-24
HWB Extractor Orthopedic Class 1 888.4540 2024-09-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-10-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-10-26
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-10-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-10-26
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-09-11
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2023-12-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-03-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2022-02-02
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-10-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-11-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-11-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-11-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-11-20
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-11-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-11-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-12-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-12-13
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2023-10-30
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2023-10-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-11-20
HXG Tamp Orthopedic Class 1 888.4540 2020-11-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-01-29
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2021-01-29
HXX Screwdriver Orthopedic Class 1 888.4540 2023-01-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-09-23
PGM Growing Rod System Orthopedic Class 2 888.3070 2025-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-11-20
JEB Table, Surgical With Orthopedic Accessories, Manual General, Plastic Surgery Class 1 878.4950 2019-09-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-07-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-09-25
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2023-01-13
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-08-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-08-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-03
HXB Probe Orthopedic Class 1 888.4540 2024-06-24
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-10-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-10-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-10-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-10-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-10-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-10-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-10-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2019-06-14
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-04-03
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2020-11-25

Official Correspondent

Michael Winkelman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

B&J Medical
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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009973699. Last updated year: 2026. Please use registration number 3009973699 when referencing this establishment in official correspondence.
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