FDA Registration
Active
🇺🇸 United States
WISHBONE MEDICAL INC.
Reg #: 3013680140
·
FEI: 3013680140
·
Expires 2026
Products
18
Proprietary Names
14
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- WISHBONE MEDICAL INC.
- Registration Number
- 3013680140
- FEI Number
- 3013680140
- 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
- K192674
Owner / Operator
- Firm Name
- Red Star Contract Manufacturing
- Operator Number
- 10055139
- 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 |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-12-15 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2017-07-25 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2017-09-27 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-07-14 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-11-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-11-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-01-25 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2021-08-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-08-21 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-02-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-02-15 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2022-07-19 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2017-12-22 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2019-08-21 |
| Splint, Denis Brown | ITN | Class 1 | Physical Medicine | No | 2022-12-15 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2021-08-26 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-11-27 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2021-08-26 |
Proprietary Names
WishBone MG
WishBone Broken Screw Removal System
WishBone Plate and Screw
WishFIX
AlloMate Arthroscopic OCD Instrument System
AlloMate Instrument System
WishBone K-Wire System
Smart Correction
Wishbone Medical K-Wire System
Iowa Brace
Dobbs Bar
PRIMA Femoral Locking Plate System
Micro Surgery Kit
Minor Surgery Kit
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198