Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000491390

FEI Number

1000491390

Entity Name

TRIANGLE MANUFACTURING CO., INC.

City/State/Country

UPPER SADDLE RIVER, NJ, US

Establishment Address

25 Park Way, UPPER SADDLE RIVER, NJ 07458, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TRIANGLE MANUFACTURING CO., INC. (Owner Number: 9056000)

Owner / Operator Contact Address

25 PARK WAY, Upper Saddle River, NJ 07458, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

T6 Screwdriver Cannulated GraftPro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-01-30
MOQ	Battery, Replacement, Rechargeable	General, Plastic Surgery	Class 1	878.4820	2013-12-20
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2020-12-07
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-28
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2016-10-13
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-12-08
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-12-20
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TRIANGLE MANUFACTURING CO., INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2018	Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446	1	Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
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

Similar Registrations

Registration Number	Establishment Name	Location
3044090645	MEDUSA ORTHOPEDICS, LLC	Fleetwood, PA, US
3021680719	QUALITEX NE LLC	Columbia City, IN, US
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015869121	Jabil Switzerland Manufacturing GmbH (Raron)	Raron Valais, CH
1043653	ONYX MEDICAL LLC	MEMPHIS, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000491390. Last updated year: 2026. Please use registration number 1000491390 when referencing this establishment in official correspondence.