Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031232974

FEI Number

3031232974

Entity Name

ZygoFix

City/State/Country

D.N. Misgav Northern, IL

Establishment Address

17 Tchelet Street, Misgav Industrial Park, D.N. Misgav Northern 2017400, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Qsite (Owner Number: 10090737)

Owner / Operator Contact Address

31 Haavoda Street, Binyamina, IL-Z 3054431, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242650

PMA Number

N/A

All Registered Proprietary Names

zLOCK Lumbar Facet Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2024-10-01

Official Correspondent

Yoram Levy

US Agent Details

Tova Rivnay Business: Qsite Email: tova@qsitemed.com Phone: (512) 5354930

Related Public Records

Same Entity

Qsite

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011096386	MeMed Diagnostics Ltd	Tirat Carmel Haifa, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K173198	U&I Corporation	Facet Screw Fixation System	2018-01-03
K121850	Choicespine, LP	Typhoon(TM) Facet Screw Fixation System	2012-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

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3005031160	Xtant Medical Holdings, Inc.	Belgrade, MT, US
3023852420	Hipp Medical AG	Renquishausen Baden-Wurttemberg, DE
3016443334	SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED	KADI Gujarat, IN
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031232974. Last updated year: 2026. Please use registration number 3031232974 when referencing this establishment in official correspondence.