FDA Registration
Active
🇺🇸 United States
RMS CO.
Reg #: 2183946
·
FEI: 1000116116
·
Expires 2026
Products
59
Proprietary Names
89
Establishment Types
1
Classifications
59
Registration Details
- Registration Name
- RMS CO.
- Registration Number
- 2183946
- FEI Number
- 1000116116
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8600 EVERGREEN BLVD.
- City
- MINNEAPOLIS
- State
- MN
- ZIP
- 55433
- Country
- US
Owner / Operator
- Firm Name
- THE CRETEX COMPANIES, INC.
- Operator Number
- 9001389
- Address
- 311 LOWELL AVE., --
- City
- Elk River
- State
- MN
- Postal Code
- 55330
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-03-06 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-06-07 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-04-22 |
| Wire, Fixation, Intraosseous | DZK | Class 2 | Dental | No | 2013-04-22 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-11-14 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-24 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-02-13 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-02-13 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-02-13 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-24 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-07-17 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-07-17 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-07-17 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-24 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2019-09-05 |
| Internal Hinged Elbow Fixator | OZI | Class 2 | Orthopedic | No | 2019-09-05 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-25 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2013-01-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-12-26 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2013-03-06 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-09-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-09-15 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-09-15 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-09-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-09-15 |
| Semi-Constrained Metal/Polymer Finger Joint Prosthesis | MPK | Class f | Unknown | No | 2013-01-28 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-01-28 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-02-15 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2019-09-05 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2013-01-28 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-01-25 |
| Vertebral Body Tethering System | QHP | Class N | Unknown | No | 2024-01-30 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2013-01-25 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2013-01-25 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2013-01-25 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2013-02-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 1996-04-01 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2013-01-25 |
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | Class 2 | Orthopedic | No | 2016-03-07 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-01-24 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-25 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-01-28 |
| Prosthesis, Finger, Constrained, Metal/Polymer | KWG | Class 3 | Orthopedic | No | 2013-01-28 |
| Prosthesis, Finger, Constrained, Polymer | KYJ | Class 2 | Orthopedic | No | 2016-03-07 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-01-24 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2021-05-13 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-06-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2017-06-07 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2017-06-07 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2014-08-27 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2020-02-25 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2015-05-20 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-01-25 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2013-01-28 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2025-12-01 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2013-01-24 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2013-01-24 |
Proprietary Names
Forerunner Locking Plate System
BacFix Thoracolumber Fusion System
MODIFIED DISTAL RADIUS PLATING SYSTEM
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
Zimmer Persona Personalized Knee System
Proximal Humerus Plating System
InCompass Thoracolumber Fusion System
InCompass System
Plate, Fixation, bone
DVR Dorsal Plate
DVR Lateral Plate
DVR Ulna Plate
MaxForce MTP
Redondo
EXPLOR RADIAL HEAD PLATING SYSTEM
Plate, fixation, bone
Trinica (ALP)
Mako Shoulder Application
Identity Revision
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 SMA
Titan Reverse Shoulder System
Harmony
INnate Cannulated Screw System
Total Foot System
Arthrex Fracture Plates
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
Fortitude
The Tether
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
TraXis
DigiFuse Cannulated Intramedullary Fusion System
Capture Screw System
Ti6 Internal Fixation System
V2F
Harmony Posterior
Optio-C (Anterior Cervical System)
Unicompartmental Knee System Spacer Block 5 Degrees 14 Mm Thickness
POST WALL IMPACTOR LEFT 24MM
OXF MP 10DEG FMRL DRL GD MED
OXF MP 10DEG FMRL DRL GD XL
OSTEOTOME IMPACTOR LEFT 21MM
OSTEOTOME IMPACTOR RIGHT 24MM
90 DEG OSTEOTOME 10X10MM
CURVED OSTOTOME 12MM
OXF MP 10DEG FMRL DRL GD XS
STRAIGHT OSTOTOME 12MM
IMPACTOR OSTEO ASM 24MM R
OXF MP 10DEG FMRL DRILL GUIDE
HEADLESS PIN PULLER
STRAIGHT CURETTE 5MM
IMPACTOR OSTEO ASM 21MM L
CURVED OSTEOTOME 6MM
CUP CURETTE RIGHT 5MM
CUP CURETTE LEFT 5MM
RASP STRAIGHT
MIS FLEX SPACER ADAPTER 3.4MM
OXF MP 10DEG FMRL DRL GD LG
TELESCOPING LOCKING BOOM
IMPACTOR OSTEO ASM 24MM L
Low Profile VA Locking Screw
Mini Fragment System
InFix Lumber Interbody Spacer System
Alliance Glenoid
IDENTITY
ARTHREX SMALL FRAGMENT PLATE AND SCREWS
INFrame Cannulated Fixation System
Panta 2 Arthrodesis Nail System
Shoulder Fixation System
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
Trauma Internal Fixation System
DVR Anatomic Plate
Mojave
Arthrex Plates, Screws, and Staples
Sierra
Single/multiple component metallic bone fixation appliances and accessories
A.L.P.S. Clavicle Plating System
Arthrex Compression Screw
Sonoma Anterior Cervical Plate 4 Level Plate
Ardis (Interbody System)
LOW PROFILE PLATE AND SCREW SYSTEM
Ardis
Distal Volar Radius Anatomical Plate System
LENS, GUIDE, INTRAOCULAR
TSC Uni-Planar Screw
T2 ICF System
Iliac Monoaxial
TI PARALLEL CONNECTOR
TraXisVue
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)