FDA.reportPublic FDA data

Kit, Container, Fixation Pins, Immobilizer

Primary DI
00860183001597
Brand
Kit, Container, Fixation Pins, Immobilizer
Company
ZAP SURGICAL SYSTEMS, INC.
Model
300159
Device description
An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session.
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
MUJSystem, Planning, Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250392000ZAP-X Radiosurgery System (ZAP-X)Zap Surgical Systems, Inc.2025-11-03IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860183001597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860183001597008601830015978601830015970860183001597

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082344400
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014658303PinZ Patient Immobilizer4658302025-11-17
00860183001542Kit, Container, Head Immobilizer3001542025-11-17
00860183001573ZAP-Axon Treatment Planning System3001572025-11-17
00860183001580DoseGuard3001582025-11-17
00860183001504Zap-X Radiosurgery System3001502018-08-29
00860183001511Zap-X Treatment Delivery Software3001512018-08-29
00860183001528Zap-X Treatment Planning Software3001522018-08-29
00860183001535Zap-X MV Imager3001532018-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355027046KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00840510401696KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00841439120590TotalRTQfixIYE2026-11-04
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937403eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00859032007392Panther TPSProwess, Inc.MUJ2026-10-14
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00859032007385Panther OISProwess, Inc.MUJ2026-09-22
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21