Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003637761

FEI Number

3003637761

Entity Name

WEST-CONN TOOL AND DIE INC

City/State/Country

Shelton, CT, US

Establishment Address

128 Long Hill Cross road, Shelton, CT 06484, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

West-Conn Tool and Die Inc (Owner Number: 10043247)

Owner / Operator Contact Address

128 Long Hill Cross Road, Shelton, CT 06484, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-31
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-01-31
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-31
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-01-31
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-31
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-01-31
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2013-01-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-31
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2013-01-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-03-16
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-03-15
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2013-01-31
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-03-15
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HXB	Probe	Orthopedic	Class 1	888.4540	2013-01-31

Official Correspondent

Laura Marasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

West-Conn Tool and Die 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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003637761. Last updated year: 2026. Please use registration number 3003637761 when referencing this establishment in official correspondence.