Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027153110

FEI Number

3027153110

Entity Name

PATHKEEPER SURGICAL LTD.

City/State/Country

Kfar-Saba Central, IL

Establishment Address

Hatachana 1, Migdal Menivim floor 1, Spaces, Kfar-Saba Central 4453001, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PathKeeper Surgical LTD. (Owner Number: 10087736)

Owner / Operator Contact Address

Hatachana 1, Migdal Menivim floor 1, Spaces, Kfar-Saba, IL-M 4453001, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222355

PMA Number

N/A

All Registered Proprietary Names

PathKeeper Surgical Navigation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-04-02

Official Correspondent

Erez Lampert

US Agent Details

Ryan LeBlanc Business: Path Keeper Email: ryan.leblanc@path-keeper.com Phone: (860) 3346493

Related Public Records

Same Entity

PathKeeper Surgical 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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027153110. Last updated year: 2026. Please use registration number 3027153110 when referencing this establishment in official correspondence.