FDA Registration
Active
🇺🇸 United States
INSTRU-MED TECHNOLOGIES
Reg #: 1833920
·
FEI: 1000115656
·
Expires 2026
Products
78
Proprietary Names
48
Establishment Types
1
Classifications
78
Registration Details
- Registration Name
- INSTRU-MED TECHNOLOGIES
- Registration Number
- 1833920
- FEI Number
- 1000115656
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 727 N Detroit St
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
Owner / Operator
- Firm Name
- Instrumedical Technologies, Inc.
- Operator Number
- 10042092
- Address
- 727 N. Detroit Street
- City
- Warsaw
- State
- IN
- Postal Code
- 46580
- Country
- US
- Correspondent
- Mitch Miller
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2024-07-31 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2026-01-29 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2013-01-28 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-02-05 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-02-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-02-05 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-02-05 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-02-05 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2014-02-05 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-05-07 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2014-05-05 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2014-05-05 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-02-05 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-12-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2026-01-29 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-01-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2026-01-29 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2026-01-29 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2026-01-29 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2020-03-24 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2026-01-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2020-04-17 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2026-01-29 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-01-24 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-29 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2020-06-23 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-01-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-01-30 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2026-01-29 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2013-03-07 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2020-02-25 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2014-05-06 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2014-05-06 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2014-05-06 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-01-30 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2018-11-30 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-05-06 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2014-05-06 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2014-05-06 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2026-01-29 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2026-01-29 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2014-05-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-01-30 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2013-01-30 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-01-28 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-01-30 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-01-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-01-30 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2026-01-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-10-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-03-07 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2018-11-21 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-11-21 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2020-10-26 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-28 |
| Bender | HXW | Class 1 | Orthopedic | No | 2025-08-12 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-03-07 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-28 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-01-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-28 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-01-31 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-01-31 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2023-01-26 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2026-01-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-01-29 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2020-03-24 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-28 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-01-28 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-01-31 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2020-05-14 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2026-01-29 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2014-05-06 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2014-05-06 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2014-05-06 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2014-05-06 |
Proprietary Names
DynaForce, Inserter Shaft Assembly
DynaForce, Standard Inserter 18mm
DynaForce, Standard Inserter, 15mm-S
DynaForce, Standard Inserter, 9mm
DynaForce, Standard Inserter, 12mm
DynaForce, Standard Inserter 20mm
DynaForce, Standard Inserter 15mm
DynaForce, Standard Inserter 25mm
No associate proprietary name
HUDSON SLIDE HAMMER
Keel-Lock Broach Assembly
Orbit
CrossRoads AO Driver Handle Assembly
DynaForce Step Staple Threaded Handle
Keel-Lock Drill Guide 25mm
Keel-Lock Drill Guide 20mm
DynaForce, Drill Guide, 18mm
Crossbar Guide Tube
DynaForce, Drill Guide, 15mm STD
DynaForce, Drill Guide, 15mm
DynaForce, Drill Guide, 20mm
Keel-Lock Broach Guide 25mm
DynaForce, Drill Guide, 12mm STD
DynaForce, Drill Guide, 9mm STD
Keel-Lock Broach Guide 18mm
DynaForce, Drill Guide, 25mm
20mm CrossBar Guide - Body
Keel-Lock Broach Guide 20mm
Keel-Lock Drill Guide 18mm
25mm CrossBar Guide - Body
18mm Crossbar Guide - Body
15-25MM STAPLE SPREADER
8-12MM STAPLE SPREADER
System Accessory (147-01045)
PARALLEL DISTRACTOR ARSENAL ANKLE PLATING SYSTEM
910-14-002 CONCAVE REAMER BLANK, 18MM
910-15-004 CONVEX REAMER BLANK, 22MM
910-15-001 CONVEX REAMER BLANK, 16MM
910-14-001 CONCAVE REAMER BLANK, 16MM
910-14-004 CONCAVE REAMER BLANK, 22MM
910-15-005 CONVEX REAMER BLANK, 24MM
910-14-005 CONCAVE REAMER BLANK, 24MM
910-14-003 CONCAVE REAMER BLANK, 20MM
910-15-003 CONVEX REAMER BLANK, 20MM
910-15-002 CONVEX REAMER BLANK, 18MM
CrossRoads Staple Tamp
LLIF INLINE INSERTER
LLIF ANGLED INSERTER
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)