Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015526568

FEI Number

3015526568

Entity Name

TRIANGLE MACHINE, INC.

City/State/Country

South Bend, IN, US

Establishment Address

3702 W. Sample Street Suite 1125, South Bend, IN 46619, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Triangle Machine, Inc. (Owner Number: 10060587)

Owner / Operator Contact Address

3702 W. Sample Street Suite 1125, South Bend, IN 46619, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zimmer Biomet LOCKING SCREW DRIVER SMALL HEAD HOLDING PINS UNIVERSAL HANDLE HANDLE/PEG DRIVER MINITHREADED ROD STEM PROV ADAPTER STRAIGHT BUSHING Zimmer Biomet Zimmer Biomet Zimmer Biomet CENTER PROBE TIBIA ALIGNMENT ROD Zimmer Biomet CPT 12/14 TAMP EXTRACTOR ROD CPT 12/14 PROX PACKER X-SMALL Zimmer Biomet CPT 12/14 LOCKING SCREW CPT 12/14 CURVED PROX PACK SML 0

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-12-13
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-02-24
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-12-13
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-12-13
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2019-05-29
FZH	Apparatus, Air Handling, Room	General, Plastic Surgery	Class 2	878.5070	2019-12-13

Official Correspondent

Mai Tran

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Triangle Machine, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015526568. Last updated year: 2026. Please use registration number 3015526568 when referencing this establishment in official correspondence.