FDA.reportPublic FDA data

MaxView™ System - Posterior Set

Primary DI
00850007069049
Brand
MaxView™ System - Posterior Set
Company
VISEON, INC.
Model
VSY-1680
Device description
Spinal access and visualization system, 16mm diameter, 80mm length
Published
2021-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191579000Voyant SystemViseon, Inc.2019-07-11HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007069049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007069049008500070690498500070690490850007069049

GMDN Terms#

Term, Definition table
TermDefinition
Spinal endoscopic-access systemAn assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-662-3959customerservice@viseon-spine.com

Regulatory Flags#

DUNS number
096680671
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007069650MISScope 4KVSY-18502024-02-06
00850007069407Imager Adaptor for NuVasive® MaXcess® 4 RetractorNUX-S2024-02-05
00850007069414Imager Adaptor for Globus Mars™3VL RetractorGLO-S2024-02-05
00850007069421Imager Adaptor for Alphatec PTP™ RetractorATC-S2024-02-05
00850007069476Imager Adaptor for Stryker Niagra® RetractorSKN-S2024-02-05
00850007069599Imager Adaptor for Medtronic® OLIF25 RetractorMDT-S2024-02-05
00850007069605Imager Adaptor for TeDan Phantom XL3™ RetractorTD3-S2024-02-05
00850007069612Imager Adaptor for SeaSpine® Lattus RetractorLTS-S2024-02-05
00850007069636Imager Adaptor for Medtronic® OLIF51 RetractorM51-S2024-02-05
00850007069346MaxView System - Lateral SetMAX-012024-02-05
00850007069353MaxView System - Lateral SetMAX-022024-02-05
00850007069360Imager Adaptor for NuVasive® MaXcess® 4 RetractorNUX-S2024-02-05
00850007069377Imager Adaptor for Globus Mars™3VL RetractorGLO-S2024-02-05
00850007069391Imager Adaptor for Alphatec PTP™ RetractorATC-S2024-02-05
00850007069445Image Control BoxICB-4K2024-02-05
00850007069438Imager Adaptor for Stryker Niagra® RetractorSKN-S2024-02-05
00850007069483MaxView 4K, Lateral ImagerMAX-L102024-02-05
00850007069490MaxView 4K, Lateral ImagerMAX-L202024-02-05
00850007069452Imager Adaptor for Medtronic® OLIF25 RetractorMDT-S2024-02-05
00850007069469Imager Adaptor for TeDan Phantom XL3™ RetractorTD3-S2024-02-05

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