Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018565653

FEI Number

3018565653

Entity Name

MICROPORT NAVIBOT INTERNATIONAL LLC

City/State/Country

Arlington, TN, US

Establishment Address

5677 Airline Rd, Arlington, TN 38002, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MicroPort NaviBot (Owner Number: 10085741)

Owner / Operator Contact Address

5677 Airline Road, Arlington, TN 38002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213873

PMA Number

N/A

All Registered Proprietary Names

SkyWalker Total Knee 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	2022-07-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MicroPort NaviBot

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

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3020983478	ORTHOKEY ITALIA SRL	Firenze, IT
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018565653. Last updated year: 2026. Please use registration number 3018565653 when referencing this establishment in official correspondence.