Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003596442

FEI Number

3003596442

Entity Name

TRIGON AMERICA LLC

City/State/Country

Aurora, IL, US

Establishment Address

4000 Sussex Ave, Aurora, IL 60504, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Trigon America (Owner Number: 9047892)

Owner / Operator Contact Address

4000 Sussex Ave, --, Aurora, IL 60504, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BROACH GUIDE, SURGICAL, INSTRUMENT BIT, DRILL EXTRACTOR DRIVER, PROSTHESIS REAMER DEPTH GAUGE AWL DISPOSABLE SURGICAL INSTRUMENT Orthopedic Manual Surgical Instrument PERSONA REVISION KNEE SYSTEM GENERAL INSTRUMENTATION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTQ	Broach	Orthopedic	Class 1	888.4540	2026-01-19
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-12-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-12-07
HWB	Extractor	Orthopedic	Class 1	888.4540	2012-12-07
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2012-12-07
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-12-10
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2026-01-19
HWJ	Awl	Orthopedic	Class 1	888.4540	2012-12-10
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-01-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-12-12
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-03-01

Official Correspondent

Tom Fenoglio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Trigon America

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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
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

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1038671	EXACTECH, INC.	GAINESVILLE, FL, US
2031009	TRIMED, INC.	Santa Clarita, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003596442. Last updated year: 2026. Please use registration number 3003596442 when referencing this establishment in official correspondence.