SURGICAL INSTRUMENT MANUFACTURERS, LLC

FDA Device Registration & Listing · FENTON, MO, US · Registration 1935627

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
1935627
FEI Number
1935627
Entity Name
SURGICAL INSTRUMENT MANUFACTURERS, LLC
City/State/Country
FENTON, MO, US
Establishment Address
2076 Fenton Logistics Park, FENTON, MO 63026, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SURGICAL INSTRUMENT MANUFACTURERS, LLC (Owner Number: 1935627)
Owner / Operator Contact Address
2076 Fenton Logistics Park Blvd., --, Fenton, MO 63026, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Curette FORCEPS, GENERAL & PLASTIC SURGERY FOUNDATION 3D INTERBODY SYSTEM CURETTE, EAR LS SYSTEM CREO MIS Stabilization System KIT, SURGICAL INSTRUMENT, DISPOSABLE CANNULA, OPHTHALMIC ELSA GUIDE WIRE GRIPPER- PLIERS, SURGICAL CURETTE, OPHTHALMIC LOOP, WIRE BIT, DRILL INSTRUMENT, BENDING OR CONTOURING K-WIRE GRIPPER RING, OPHTHALMIC SCREWDRIVER TAMP HOOK, OPHTHALMIC INSTRUMENT, COMPRESSION RETRACTOR KNIFE, OPHTHALMIC TAP, BONE HOOK, SURGICAL, GENERAL & PLASTIC SURGERY FORCEPS, OPHTHALMIC KNIFE, EAR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT STARTER, BONE SCREW SPECULA, OPHTHALMIC INSTRUMENTS, SURGICAL, CARDIOVASCULAR DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY Awl Foreign Body Spud TRANSCONTINENTAL BENDER CURETTE, NASAL BURR, ORTHOPEDIC RETRACTOR, OPHTHALMIC ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY Microinstrument Basket BROACH EXTRACTOR SPATULA, OPHTHALMIC SCISSORS, OPHTHALMIC IMPACTOR DRIVER, PROSTHESIS

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 2015-12-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-07-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-07-17
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-07-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-10-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-30
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-12-30
HTF Curette General, Plastic Surgery Class 1 878.4800 2015-12-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-17
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-07-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-12-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-10-24
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-12-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-10-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-10-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-24
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-12-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-12-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-12-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-12-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-12-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-12-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-17
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 1992-12-14
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2016-12-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-10-24
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-07-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-07-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-17
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-07-17
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 1992-12-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-12-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-12-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-12-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-12-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-12-09
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2015-12-30
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 1992-12-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-17
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2026-04-02
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2015-12-30
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2007-11-20
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2016-12-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2014-12-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-30
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 1992-12-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-17
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-11-20
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2015-12-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-10-24
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-12-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-12-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-10-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-04-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-07-17
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2007-11-20
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-10-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-10-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-10-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-30
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2015-12-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-30
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2015-12-30
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2007-11-20
HXX Screwdriver Orthopedic Class 1 888.4540 2007-11-20
HXG Tamp Orthopedic Class 1 888.4540 2007-11-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-12-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2014-12-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-12-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-12-31
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 1992-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-31
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-12-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-12-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-12-09
HWN Instrument, Compression Orthopedic Class 1 888.4540 2007-11-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-10-24
GAD Retractor General, Plastic Surgery Class 1 878.4800 1992-12-14
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 1992-12-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-17
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2015-12-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-30
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2021-10-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-12-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-12-31
HWX Tap, Bone Orthopedic Class 1 888.4540 2007-11-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-10-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-12-09
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-12-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-12-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-12-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-12-30
PLF Bone Wedge Orthopedic Class 2 888.3030 2021-10-24
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 1992-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-12-09
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 1978-06-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-10-24
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-11-19
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2007-11-20
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 1992-12-14
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1992-12-14
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-12-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-10-24
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2021-10-24
HWJ Awl Orthopedic Class 1 888.4540 2007-11-20
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2013-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-04-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-17
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-07-17
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-07-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-30
HXW Bender Orthopedic Class 1 888.4540 2007-11-20
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2014-12-09
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 1992-12-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-17
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2015-12-30
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2007-11-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-07-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-07-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-17
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2007-11-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-12-30
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2021-10-24
HTE Elevator General, Plastic Surgery Class 1 878.4800 2015-12-30
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-12-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-04-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-20
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2021-02-16
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-04-20
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-12-30
HTQ Broach Orthopedic Class 1 888.4540 2007-11-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-12-31
HWB Extractor Orthopedic Class 1 888.4540 2007-11-20
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 1992-12-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-07-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-31
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-31
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-12-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-30
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 1992-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-12-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-12-30
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-07-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-07-17
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-31
HWA Impactor Orthopedic Class 1 888.4540 2007-11-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-12-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-12-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-12-30
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2016-12-30

Official Correspondent

Steve Gordon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SURGICAL INSTRUMENT MANUFACTURERS, 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
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05

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-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).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1935627. Last updated year: 2026. Please use registration number 1935627 when referencing this establishment in official correspondence.
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