FDA Registration
Active
🇺🇸 United States
TriPoint Surgical
Reg #: 3009973844
·
FEI: 3009973844
·
Expires 2026
Products
13
Proprietary Names
9
Establishment Types
1
Classifications
13
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Registration Details
- Registration Name
- TriPoint Surgical
- Registration Number
- 3009973844
- FEI Number
- 3009973844
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 201 S Towerview Dr
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Owner / Operator
- Firm Name
- TriPoint Surgical
- Operator Number
- 10042633
- Address
- 201 S.Towerview Drive
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
- Correspondent
- Anthony A Lozano
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Broach | HTQ | Class 1 | Orthopedic | No | 2012-12-14 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2016-04-13 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2019-10-11 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2016-04-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-04-13 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-01-13 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-01-13 |
| File | HTP | Class 1 | Orthopedic | No | 2016-04-13 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-03-11 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-04-13 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2016-04-13 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2021-04-13 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2016-04-13 |
Proprietary Names
Reamer
Tap, Bone
Orthopedic Manual Surgical Instrument
Comprehensive Shoulder System
File
Drill Bits
Screwdriver
Rasp
Starter, Bone Screw
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)