Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006765019

FEI Number

3006765019

Entity Name

Medfix International, LLC

City/State/Country

Tucson, AZ, US

Establishment Address

5620 North Kolb Road, Suite 225, Tucson, AZ 85750, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medfix International, LLC (Owner Number: 10031262)

Owner / Operator Contact Address

2109 E. Grant Rd., Tucson, AZ 85719, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medfix® Orthopedic Manual Surgical Instruments Medfix® Fiberoptic Retractor Light Cable Medfix® Non-Powered Surgical Instruments Medfix® Rongeurs Medfix® Screwdrivers Medfix® Depth Gauge Medfix® Light Source Medfix® Probes Medfix® Surgical Curettes Medfix® VISION Retractors

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	2013-03-12
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2019-05-17
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2019-12-12
HTX	Rongeur	Orthopedic	Class 1	888.4540	2019-04-26
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2019-05-17
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2019-04-26
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2019-05-17
HXB	Probe	Orthopedic	Class 1	888.4540	2019-04-26
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-04-26
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-03-12

Official Correspondent

Joseph Samaha

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medfix International, LLC

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

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006765019. Last updated year: 2026. Please use registration number 3006765019 when referencing this establishment in official correspondence.