FDA Registration
Active
🇺🇸 United States
TIGON MEDICAL LLC
Reg #: 3015075784
·
FEI: 3015075784
·
Expires 2026
Products
4
Proprietary Names
20
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- TIGON MEDICAL LLC
- Registration Number
- 3015075784
- FEI Number
- 3015075784
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 303 Najoles Road, Suite 104
- City
- Millersville
- State
- MD
- ZIP
- 21108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182507
Owner / Operator
- Firm Name
- Tigon Medical LLC
- Operator Number
- 10059738
- Address
- 303 Najoles Road, Suite 104
- City
- Millersville
- State
- MD
- Postal Code
- 21108
- Country
- US
- Correspondent
- Jeremy Clark
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2019-02-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-01-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-01-07 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-08-26 |
Proprietary Names
Manticore
Tigon Tomahawk, Dual Infinity, Eye-Deal, and Tenodesis Anchors
Boomerang Button
Tigon Medical Javelin All-Suture Anchors
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
TIGO PRO 009 Birdy Left
TIGO PRO 002 Shoulder Debridement Rasp
TIGO PRO 006 Suture Retriever
TIGO PRO 001 Knot Pusher
TIGO PRO 007 Tissue Grasper
TIGO PRO 003 Shoulder Tissue Elevator
TIGO PRO 005 Suture Cutter Ring Handle
TIGO PRO 008 Birdy Right
TIGO-11 Suture Passer
TIGO PRO 004 Suture Cutter Axial Handle
TIGO-12 Needle for Passer
NDC (Non-Disposable Cannula)
Vampire Awl & Fang
Lasso Suture Passer
Knotless and Dual Javelin All-Suture Anchors
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility