FDA Registration
Active
🇺🇸 United States
Metal Craft Machine & Engineering, Inc.
Reg #: 2133928
·
FEI: 3000717902
·
Expires 2026
Products
89
Proprietary Names
18
Establishment Types
1
Classifications
89
Registration Details
- Registration Name
- Metal Craft Machine & Engineering, Inc.
- Registration Number
- 2133928
- FEI Number
- 3000717902
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13760 Business Center Drive
- City
- Elk River
- State
- MN
- ZIP
- 55330
- 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, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-02-22 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2016-03-28 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-05-17 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2015-01-12 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2015-01-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2015-01-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2015-01-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2015-01-12 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2015-01-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2015-01-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2015-01-12 |
| 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 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-04-06 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-02-01 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2017-12-15 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-31 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-01-31 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-01-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-31 |
| Retainer, Surgical | GCZ | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-02-01 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-02-01 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-02-01 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-02-06 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 2013-01-31 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-02-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-02-06 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2016-03-28 |
| Penile Implant Surgical Accessories | QGA | Class 1 | Gastroenterology, Urology | No | 2020-04-09 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2016-03-28 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-31 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-01-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-01-14 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-08 |
| Tap, Bone | HWX | 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 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2014-12-31 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-31 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-05-17 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-05-17 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-02-06 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-04-06 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2013-06-07 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-02-06 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-12-20 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-31 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-31 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-12-05 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2016-03-28 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-01-31 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2015-01-12 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-01-31 |
| 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 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2013-12-19 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-31 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories | QGD | Class 1 | Gastroenterology, Urology | No | 2020-04-09 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-02-01 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-31 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-04-06 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-01-31 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-01-31 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-03-25 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2019-03-25 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2019-03-25 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-03-25 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-22 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2013-01-31 |
Proprietary Names
Triathlon Hinge Knee System
VIPER PRIME navigated inserter
2082001500 Rosa Arm Reference Frame
2082000400 Rosa Arm Instrument Interface
2082000200 Rosa Base Reference Frame
Closing Tool
Quick Connect assembly tool
Furlow Insertion Tool
Insertion Package
301019010
VIPER PRIME
4021-0629-00 RETRACTOR 6" VEIN BAK Ant Lumbar IBF (Zimmer Spine)
Triathlon
Quick Connect Assembly Tool
Viper Prime Shaft (catalog nr: 301019010)
TMR
ZMR Hip System
METAL CRAFT MACHINE & ENG INC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)