FDA Registration
Active
🇺🇸 United States
FORT WAYNE METALS RESEARCH PRODUCTS, LLC
Reg #: 1824313
·
FEI: 1824313
·
Expires 2026
Products
16
Proprietary Names
10
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- FORT WAYNE METALS RESEARCH PRODUCTS, LLC
- Registration Number
- 1824313
- FEI Number
- 1824313
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9609 Ardmore Ave
- City
- FORT WAYNE
- State
- IN
- ZIP
- 46809
- Country
- US
Owner / Operator
- Firm Name
- FORT WAYNE METALS RESEARCH PRODUCTS, LLC
- Operator Number
- 1824313
- Address
- 9609 Ardmore Ave., --
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46809
- Country
- US
- Correspondent
- Richard - Castaneda
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Passer | HWQ | Class 1 | Orthopedic | No | 2019-12-09 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-30 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-30 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2020-08-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-05-26 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2019-12-09 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2023-12-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-01-09 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-12-09 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2018-11-16 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2021-03-10 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-30 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2019-12-09 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2020-03-12 |
Proprietary Names
Sutures
Suture Passer
Loops
GIRO Growth Modulation System
Isola Spinal Wire with Button
11-1500-002 / 11-1500-006
Pins and Wires
Suture Straight Needles
Low Profile Cable System
Suture Wire
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)