FDA Registration
Active
🇺🇸 United States
RED STAR CONTRACT MANUFACTURING INC.
Reg #: 3009631939
·
FEI: 3009631939
·
Expires 2026
Products
20
Proprietary Names
16
Establishment Types
5
Classifications
20
Registration Details
- Registration Name
- RED STAR CONTRACT MANUFACTURING INC.
- Registration Number
- 3009631939
- FEI Number
- 3009631939
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1560 N State Road 5
- City
- Larwill
- State
- IN
- ZIP
- 46764
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121786
Owner / Operator
- Firm Name
- Red Star Contract Manufacturing
- Operator Number
- 10046073
- Address
- 1560 N State Road 5
- City
- Larwill
- State
- IN
- Postal Code
- 46764
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Template | HWT | Class 1 | Orthopedic | No | 2022-09-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2022-09-28 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-09-28 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2022-09-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-09-28 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2021-05-14 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2021-05-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-05-14 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-09-28 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-09-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2022-09-28 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-09-28 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2021-05-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-09-28 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-09-28 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-05-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-05-14 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-09-28 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2025-12-17 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-10-31 |
Proprietary Names
WishFIX
Sterile Spine Pedicle Screw System
WishBone Plate and Screw
Injection molded housing assembly
Drill Bit
WishBone K-Wire System
WishBone Broken Screw Removal System
Wishbone Medical K-Wire System
AlloMate Arthroscopic OCD Instrument System
AlloMate Instrument System
Smooth / Threaded / Fluted Pin
Bone Biopsy Cannula/Instrument
Nitinol Wire Loop
PRIMA Femoral Locking Plate System
Medline UNITE® REFLEX® MAX NITINOL STAPLE KIT
Cannulated Screws
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility