FDA Registration
Inactive
🇺🇸 United States
FUSIONX MEDTECH INC.
·
Expires 2026
Products
29
Proprietary Names
1
Establishment Types
2
Classifications
29
Registration Details
- Registration Name
- FUSIONX MEDTECH INC.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8108 San Lucas Dr
- City
- Whittier
- State
- CA
- ZIP
- 90605
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201737
Owner / Operator
- Firm Name
- FusionX MedTech Inc.
- Operator Number
- 10096064
- Address
- 8108 San Lucas Dr,
- City
- Whittier
- State
- CA
- Postal Code
- 90605
- Country
- US
- Correspondent
- ze wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2026-06-16 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2026-06-16 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-06-16 |
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2026-06-16 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-06-16 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2026-06-16 |
| File | HTP | Class 1 | Orthopedic | No | 2026-06-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2026-06-16 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2026-06-16 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2026-06-16 |
| Scrapper, Skin Specimen | LXK | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2026-06-16 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2026-06-16 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2026-06-16 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2026-06-16 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2026-06-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2026-06-16 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2026-06-16 |
| Bender | HXW | Class 1 | Orthopedic | No | 2026-06-16 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2026-06-16 |
Proprietary Names
Shanghai Reach Medical Instrument Co., Ltd
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device