FDA Registration
Active
🇺🇸 United States
RIVERSIDE MACHINE & ENGINEERING, INC.
Reg #: 2134285
·
FEI: 3002287318
·
Expires 2026
Products
82
Proprietary Names
9
Establishment Types
1
Classifications
82
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Registration Details
- Registration Name
- RIVERSIDE MACHINE & ENGINEERING, INC.
- Registration Number
- 2134285
- FEI Number
- 3002287318
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2445 Alpine Rd
- City
- Eau Claire
- State
- WI
- ZIP
- 54703
- Country
- US
Owner / Operator
- Firm Name
- Metal Craft and Riverside Machine & Engineering, Inc.
- Operator Number
- 9027247
- Address
- 13760 Business Drive, --
- City
- Elk River
- State
- MN
- Postal Code
- 55330
- Country
- US
- Correspondent
- Trisha L Mowry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-11-06 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-31 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-31 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-05-17 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-04-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-04-06 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-04-06 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-31 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-31 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-02-01 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2015-01-12 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-02-06 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-02-06 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-12-05 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-02-06 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-01-31 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-03-05 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-03-05 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2013-06-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-04-06 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-31 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2016-03-28 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-01-31 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-01-31 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-01-31 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-04-06 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-02-01 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Retainer, Surgical | GCZ | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-01-31 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-04-06 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-02-01 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-01-31 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-02-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-01-14 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-01-31 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-22 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-08 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2014-12-31 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2013-02-01 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-02-01 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-02-06 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-02-01 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2013-12-19 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2013-01-31 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-31 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2016-03-28 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2016-03-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-12-03 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2012-12-03 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2012-12-03 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-31 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-31 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-02-01 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2013-02-01 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2013-02-01 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2013-02-01 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-05-17 |
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 2013-01-31 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-12-20 |
Proprietary Names
ZIMMER SEGMENTAL SYSTEM TRABECULAR METAL PROXIMAL TIBIA COMPONENT TRABECULAR METAL PROXIMAL FEMORAL COMPONENT AND ADDTL SIZES OF MALE-FEMALE SEGMENTS
Triathlon
Triathlon Hinge Knee System
Zimmer Personna Personalized Knee System
METAL CRAFT MACHINE & ENG INC
Nexgen post ref sizer
nexgen post ref sizer boom
PSN P-ref sizer
PSN P-ref sizer boom
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)