FDA Registration
Active
🇺🇸 United States
ARCH Medical Solutions - Seabrook
Reg #: 1221763
·
FEI: 1221763
·
Expires 2026
Products
72
Proprietary Names
1
Establishment Types
1
Classifications
72
Registration Details
- Registration Name
- ARCH Medical Solutions - Seabrook
- Registration Number
- 1221763
- FEI Number
- 1221763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15 WOODWORKERS WAY
- City
- SEABROOK
- State
- NH
- ZIP
- 03874
- Country
- US
Owner / Operator
- Firm Name
- ARCH Medical Solutions - Seabrook
- Operator Number
- 1221763
- Address
- 15 Woodworker's Way, --
- City
- Seabrook
- State
- NH
- Postal Code
- 03874
- Country
- US
- Correspondent
- Dawn E Frazer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-07-20 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2022-07-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-07-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-07-20 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-02-14 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-29 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-01-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-29 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-29 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-30 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-04-20 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-04-20 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2013-01-30 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2025-01-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-30 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2016-08-09 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2016-08-09 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-30 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-30 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-01-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-30 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2025-01-29 |
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2025-01-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Light, Surgical, Instrument | FSQ | Class 2 | General, Plastic Surgery | No | 2013-01-30 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-01-30 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-01-30 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-01-29 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-01-29 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-01-29 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-01-29 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2025-01-29 |
| Prosthesis, Total Talus Replacement, Metal | QNN | Class f | Unknown | No | 2025-08-27 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-30 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-01-29 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-01-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-02-14 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2025-12-26 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-07-20 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-30 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-01-30 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-01-30 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-30 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2022-07-20 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-30 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2025-01-29 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-30 |
| Growing Rod System- Magnetic Actuation | PGN | Class 2 | Orthopedic | No | 2025-01-29 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2021-04-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2021-04-20 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2021-06-04 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-01-30 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2016-08-09 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
Proprietary Names
250620007-12 ATTUNE REV CEMENTED PREP PLATE SZ 7
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)