Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020650900

FEI Number

3020650900

Entity Name

ACCUFIX SURGICAL, INC.

City/State/Country

Laramie, WY, US

Establishment Address

3821 Beech St, Laramie, WY 82070, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Accufix Surgical, Inc. (Owner Number: 10082818)

Owner / Operator Contact Address

385 Main Street, Suite 5, West Haven, CT 06516, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Accu-Joint Hemi Implant Instrument Kit Accu-Joint Hemi Implant Instrument Kit Accu-Joint Hemi Implant Accu-Joint Hemi Implant Instrument Kit Accu-Joint Hemi Implant Instrument Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-09-12
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-09-12
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2021-10-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-09-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-09-12

Official Correspondent

John Evans

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Accufix Surgical, 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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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 3020650900. Last updated year: 2026. Please use registration number 3020650900 when referencing this establishment in official correspondence.