FDA Registration
Active
🇺🇸 United States
TRIANGLE MACHINE, INC.
Reg #: 3015526568
·
FEI: 3015526568
·
Expires 2026
Products
8
Proprietary Names
16
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- TRIANGLE MACHINE, INC.
- Registration Number
- 3015526568
- FEI Number
- 3015526568
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3702 W. Sample Street Suite 1125
- City
- South Bend
- State
- IN
- ZIP
- 46619
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120906
Owner / Operator
- Firm Name
- Triangle Machine, Inc.
- Operator Number
- 10060587
- Address
- 3702 W. Sample Street Suite 1125
- City
- South Bend
- State
- IN
- Postal Code
- 46619
- Country
- US
- Correspondent
- Mai Tran
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-12-13 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2020-02-24 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-12-13 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2019-12-13 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2019-05-29 |
| Apparatus, Air Handling, Room | FZH | Class 2 | General, Plastic Surgery | No | 2019-12-13 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2019-12-13 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-12-13 |
Proprietary Names
Zimmer Biomet
LOCKING SCREW DRIVER
SMALL HEAD HOLDING PINS
UNIVERSAL HANDLE
HANDLE/PEG DRIVER
MINITHREADED ROD
STEM PROV ADAPTER
STRAIGHT BUSHING
CENTER PROBE
TIBIA ALIGNMENT ROD
CPT 12/14 TAMP EXTRACTOR ROD
CPT 12/14 PROX PACKER X-SMALL
CPT 12/14 LOCKING SCREW
CPT 12/14 CURVED PROX PACK SML 0
SEG RH KNEE HINGE PIN ALIGNER
MIS6MM HEX DRIVER
Establishment Types
Manufacture Medical Device