FDA Registration
Active
🇺🇸 United States
KEYSTONE MANUFACTURING
Reg #: 3008236846
·
FEI: 3008236846
·
Expires 2026
Products
16
Proprietary Names
5
Establishment Types
3
Classifications
16
Registration Details
- Registration Name
- KEYSTONE MANUFACTURING
- Registration Number
- 3008236846
- FEI Number
- 3008236846
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6387 Technology Ave Ste B
- City
- Kalamazoo
- State
- MI
- ZIP
- 49009
- Country
- US
Owner / Operator
- Firm Name
- Keystone Manufacturing, LLC
- Operator Number
- 10031160
- Address
- 6387 Technology Avenue, Suite B
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49009
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-05-04 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-07-25 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2023-12-15 |
| Monitor, Pressure, Intracompartmental | LXC | Class U | Unknown | No | 2019-10-31 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-04-09 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2022-11-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-04-08 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2020-08-03 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2022-11-16 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-02-04 |
| Clip, Vascular | DSS | Class 2 | Cardiovascular | No | 2022-11-14 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2022-11-14 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2020-06-30 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2022-11-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2012-07-20 |
| Source, Brachytherapy, Radionuclide | KXK | Class 2 | Radiology | No | 2014-12-05 |
Proprietary Names
FastGrafter
Lapiplasty
C2Dx Intra-Compartmental Pressure Monitor System
SpeedRelease
Sirius MRI Marker
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device