Data / Medical devices / United States / Triangle Machine, Inc.
Triangle Machine, Inc.: FDA-registered device maker in South Bend, IN, United States, 1 510(k) clearance
Triangle Machine, Inc. is registered with the FDA (registration 3015526568) in South Bend, IN, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 24, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015526568
- Address
- 3702 W. Sample Street Suite 1125, South Bend, IN, United States, 46619
- Owner or operator
- Triangle Machine, Inc. (10060587)
- Roles
- Manufacturer
- First device listed
- May 29, 2019
- Registered through
- 2026
- Brand names listed
- CENTER PROBE, CPT 12/14 CURVED PROX PACK SML 0, CPT 12/14 LOCKING SCREW, CPT 12/14 PROX PACKER X-SMALL, CPT 12/14 TAMP EXTRACTOR ROD, HANDLE/PEG DRIVER, LOCKING SCREW DRIVER, MINITHREADED ROD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Air Handling, Room | FZH | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Impactor | HWA | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | 2 | Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 24, 2012 | K120906 | ZIMMER TRABECULAR METAL TOTAL ANKLE | HSN | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Impactor
- All makers of Wrench
- All makers of Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Guide, Surgical, Instrument
- All makers of Apparatus, Air Handling, Room
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Updated August 24, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.