PHASOR

Primary DI
B775EZFIDUCIALS0
Brand
PHASOR
Company
PHASOR HEALTH LLC
Model
EZ-FIDUCIALS
Catalog number
EZ-FIDUCIALS
Device description
Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, all single-use, provided gamma-sterilized, and placed within the same primary packaging (sealed Tyvek tray within a shelf carton): (1) Screws: Each of the four provided titanium screws is identical, with specific dimensions of each EZ-Fiducials screw as follows: screwhead circular shape screwhead with square-shaped engagement, non-threaded shaft diameter 2.9mm and length 15mm, threaded shaft diameter (major threads) 1.98mm, thread length 5mm; no protective caps are provided, and the screws should exclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and with no other screwdriver); (2) Manual Screwdriver: handheld, to be solely used with the screws provided, not intended for use with any other screws; (3) EZ-driver: (electric, handheld, non-rechargeable battery-operated screwdriver, without software, single-use for solely tightening or loosening the provided screws exclusively, not intended for use with any other screws).
Published
2025-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250505000EZ-FIDUCIALSPhasor Health, LLC2025-07-09HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B775EZFIDUCIALS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical tracking system spatial marker, external, non-poweredA non-powered, noninvasive component of an electromagnetic surgical tracking system intended to provide a reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure; the EM-tracking diagrams may be subsequently overlaid on radiological images for surgical navigation. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an electrically-powered marker for active registration. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(832) 982-1234info@phasorhealth.com

Regulatory Flags#

DUNS number
111926675
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B775140L0PHASOR14.0L2026-04-04
B775140S0PHASOR14.0S2026-04-04
B775110L0PHASOR11.0L2026-03-27
B775110S0PHASOR11.0S2026-03-27
B7752IN105CK0PHASOR2-IN-1-05CK2026-03-27
B7752IN125LKX0PHASOR2-IN-1-25LKX2026-03-27
B7752IN1260PHASOR2-IN-1-262026-03-28
B7752IN145CK0PHASOR2-IN-1-45CK2026-03-28
B7753IN1245K0PHASOR3-IN-1-245K2026-03-27
B7753IN1256CK0PHASOR3-IN-1-256CK2026-03-28
B7753IN145RK0PHASOR3-IN-1-45RK2026-03-28
B7754IN12456K0PHASOR4-IN-1-2456K2026-03-28
B775840L0PHASOR8.40L2026-03-27
B775840S0PHASOR8.40S2026-03-27
B775635CK0PHASOR6.35CK2026-01-19
B7752IN125LK0PHASOR2-IN-1-25LK2025-11-24
B7752IN126LK0PHASOR2-IN-1-26LK2025-11-24
B7752IN145LK0PHASOR2-IN-1-45LK2025-11-24
B7753IN1246LK0PHASOR3-IN-1-246LK2025-11-24
B7753IN1256LK0PHASOR3-IN-1-256LK2025-11-24

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07340201503959Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
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04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25