FDA.reportPublic FDA data

VySpan™

Primary DI
00840283403897
Brand
VySpan™
Company
VY SPINE LLC
Model
05-CRR7-3535-TI-N
Device description
Connector, Rod-to-Rod, Wide, Ø3.5 to Ø3.5, 7mm, Ti 6Al-4V
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223852000VySpan™ PCT SystemVy Spine, LLC2023-02-24NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840283403897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840283403897008402834038978402834038970840283403897

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
866-489-7746info@vyspine.com

Regulatory Flags#

DUNS number
049592888
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840283403460LumiVy™03-T-0927-0-06-PET-R2026-06-05
00840283403927VySpan™05-CRR10-3540-TI-N2026-06-05
00840283407949VyPlate™06-IPH-0022026-06-05
00840283403477LumiVy™03-T-0927-0-07-PET-R2026-04-30
00840283403484LumiVy™03-T-0927-0-08-PET-R2026-04-30
00840283403491LumiVy™03-T-0927-0-09-PET-R2026-04-30
00840283403507LumiVy™03-T-0927-0-10-PET-R2026-04-30
00840283403514LumiVy™03-T-0927-0-11-PET-R2026-04-29
00840283403521LumiVy™03-T-0927-0-12-PET-R2026-04-28
00840283403538LumiVy™03-T-0927-0-13-PET-R2026-04-28
00840283403545LumiVy™03-T-0927-0-14-PET-R2026-04-28
00840283403552LumiVy™03-T-0927-0-15-PET-R2026-04-28
00840283403576LumiVy™03-A-3427-6-09-PET-R2026-04-27
00840283403583LumiVy™03-A-3427-6-10-PET-R2026-04-27
00840283403590LumiVy™03-A-3427-6-11-PET-R2026-04-27
00840283403606LumiVy™03-A-3427-6-12-PET-R2026-04-27
00840283403613LumiVy™03-A-3427-6-13-PET-R2026-04-27
00840283403620LumiVy™03-A-3427-6-14-PET-R2026-04-27
00840283403569LumiVy™03-A-3427-6-08-PET-R2026-04-24
00840283404139ClariVy™02-ITL-1210-082026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982239862CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239886CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239909CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239923CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239947CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239961CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240240CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240363CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240622CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450151CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450168CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450175CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450182CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450199CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521134QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521134QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14