Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016926753

FEI Number

3016926753

Entity Name

ARCURO MEDICAL LTD.

City/State/Country

Misgav Northern, IL

Establishment Address

17 Tchelet St., Misgav Business Park, Misgav Northern 2017400, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Arcuro Medical Ltd. (Owner Number: 10074120)

Owner / Operator Contact Address

17 Tchelet St., Misgav Business Park, Misgav, IL-NOTA 2017400, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223500

PMA Number

N/A

All Registered Proprietary Names

SuperBall-RC 12 degree inserter SuperBall Meniscal Repair System, 24 Up SuperBall Meniscal Repair System, 12 Reverse SuperBall Meniscal Repair System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-06-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-30
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-30

Official Correspondent

Dan Shlezak

US Agent Details

Jamal Rushdy Business: Arcuro Medical Inc. Email: jamal.rushdy@arcuromedical.com Phone: (612) 4057709

Related Public Records

Same Entity

Arcuro Medical Ltd.

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
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016926753. Last updated year: 2026. Please use registration number 3016926753 when referencing this establishment in official correspondence.