FDA.reportPublic FDA data

VySpan™

Primary DI
00840283400407
Brand
VySpan™
Company
VY SPINE LLC
Model
05-SS-001-TI-N
Device description
Set Screw, Ti 6Al-4V
Published
2024-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K213394000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213394000Vy Spine™ VySpan™ PCT SystemVy Spine, LLC2021-12-10NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840283400407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840283400407008402834004078402834004070840283400407

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840283404146ClariVy™02-ITL-1210-092026-04-24
00840283405549ClariVy™02-ITL-1411-042026-04-24
00840283405556ClariVy™02-ITL-1411-052026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613154111725OASYSStryker CorporationKWP2015-09-14
07613154129867OASYSStryker CorporationKWP2015-09-14
07613154129874OASYSStryker CorporationNKG2015-09-14
07613154170135OASYSStryker CorporationNKG2015-09-14
07613154170142OASYSStryker CorporationKWP2015-09-14
07613154170159OASYSStryker CorporationNKG2015-09-14
07613154170166OASYSStryker CorporationKWP2015-09-14
07613154253883OASYSStryker CorporationNKG2015-09-14
07613154345014MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345021MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345038MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345045MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345052MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345069MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345090MAC TITANIUMStryker CorporationKWP2015-09-14
07613154408085OASYSStryker CorporationNKG2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08