FDA Registration
Active
🇺🇸 United States
AVALIGN TECHNOLOGIES, Inc.
Reg #: 3008864603
·
FEI: 3008864603
·
Expires 2026
Products
34
Proprietary Names
0
Establishment Types
1
Classifications
34
Registration Details
- Registration Name
- AVALIGN TECHNOLOGIES, Inc.
- Registration Number
- 3008864603
- FEI Number
- 3008864603
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8727 Clinton Park Dr
- City
- Fort Wayne
- State
- IN
- ZIP
- 46825
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100517
Owner / Operator
- Firm Name
- Avalign Technologies
- Operator Number
- 10051835
- Address
- 110275 W. Higgins Rd, Suite 920
- City
- Rosemont
- State
- IL
- Postal Code
- 60018
- Country
- US
- Correspondent
- Heidi Funston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-02-03 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2016-05-09 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2016-09-21 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-11-17 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2016-09-21 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2018-05-30 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2016-09-21 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-07-02 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-09-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-09-21 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2017-03-13 |
| Template | HWT | Class 1 | Orthopedic | No | 2016-05-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-05-09 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2016-05-09 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2016-09-21 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2018-03-28 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2016-11-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-07-25 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-07-25 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2016-09-21 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2016-09-21 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2019-02-26 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2016-09-21 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility