FDA Registration
Active
🇺🇸 United States
SURGICAL INSTRUMENT MANUFACTURERS, LLC
Reg #: 1935627
·
FEI: 1935627
·
Expires 2026
Products
87
Proprietary Names
62
Establishment Types
1
Classifications
87
Registration Details
- Registration Name
- SURGICAL INSTRUMENT MANUFACTURERS, LLC
- Registration Number
- 1935627
- FEI Number
- 1935627
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2076 Fenton Logistics Park
- City
- FENTON
- State
- MO
- ZIP
- 63026
- Country
- US
Owner / Operator
- Firm Name
- SURGICAL INSTRUMENT MANUFACTURERS, LLC
- Operator Number
- 1935627
- Address
- 2076 Fenton Logistics Park Blvd., --
- City
- Fenton
- State
- MO
- Postal Code
- 63026
- Country
- US
- Correspondent
- Steve Gordon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-12-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-07-17 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-07-17 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-07-17 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-07-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-07-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-12-30 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2021-10-24 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-07-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-10-24 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-10-24 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-12-30 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1992-12-14 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2016-12-30 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2015-12-30 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1992-12-14 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2026-04-02 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2007-11-20 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2016-12-30 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2014-12-09 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 1992-12-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2007-11-20 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2015-12-30 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-07-17 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2007-11-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-12-30 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2015-12-30 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2015-12-30 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2007-11-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2007-11-20 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2007-11-20 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1992-12-14 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2007-11-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1992-12-14 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2015-12-30 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2007-11-20 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2021-10-24 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1992-12-14 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 1978-06-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-11-19 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2007-11-20 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1992-12-14 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1992-12-14 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2021-10-24 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2007-11-20 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2013-01-17 |
| Bender | HXW | Class 1 | Orthopedic | No | 2007-11-20 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 1992-12-14 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2007-11-20 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2007-11-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2021-10-24 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1992-12-14 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-02-16 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2025-07-17 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2007-11-20 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2007-11-20 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1992-12-14 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1992-12-14 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2007-11-20 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2016-12-30 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1992-12-14 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2016-12-30 |
| Probe | HXB | Class 1 | Orthopedic | No | 2007-11-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2015-12-30 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1992-12-14 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2021-10-24 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 1992-12-14 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-12-31 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 1992-12-14 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 1992-12-14 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2007-11-20 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2015-12-30 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-17 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2016-12-30 |
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
DILATOR, LACHRYMAL
PROBE
CORELINK LATERAL PLATE SYSTEM
TUBE, EAR SUCTION
Rasp
INSTRUMENT, MICROSURGICAL
NEEDLE, OPHTHALMIC SUTURING
CAPSTONE SPINAL SYSTEM
CLIP, IRIS RETRACTOR
RONGEUR
Template for clinical use
Manual Surgical Instrument
Implant Caddy
REAMER
OSTEOTOME
HOURGLASS VERTEBRAL BODY SPACER
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)