Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016577622

FEI Number

3016577622

Entity Name

PHASOR HEALTH, LLC

City/State/Country

Houston, TX, US

Establishment Address

8944 Kirby Drive, Houston, TX 77054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Phasor Health, LLC (Owner Number: 10062497)

Owner / Operator Contact Address

8944 Kirby Drive, Houston, TX 77054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EVAC EZ-Fiducials Green Phasor Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2025-08-13
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-08-13
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2025-11-21
OJG	Neurological Tray	Neurology	Class 1	882.4525	2024-10-22

Official Correspondent

Ray King

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Phasor Health, 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
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

Similar Registrations

Registration Number	Establishment Name	Location
3015531529	Medtronic Neurosurgery	Fort Worth, TX, US
3004593495	Plexus Manufacturing Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3012507533	Integra Canada ULC	Oakville Ontario, CA
3003418325	Integra LifeSciences Corporation	Princeton, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016577622. Last updated year: 2026. Please use registration number 3016577622 when referencing this establishment in official correspondence.