FDA.reportPublic FDA data

VyPlate™

Primary DI
00840283401831
Brand
VyPlate™
Company
VY SPINE LLC
Model
06-TF-45-16-TI-N
Device description
Tapping, Fixed Screw, Ø4.5x16mm, Ti 6Al-4V
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221572000VyPlate Anterior Cervical Plate SystemVy Spine, LLC2022-07-26KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840283401831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840283401831008402834018318402834018310840283401831

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
00840283403460LumiVy™03-T-0927-0-06-PET-R2026-06-05
00840283403897VySpan™05-CRR7-3535-TI-N2026-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986492791CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08