FDA.reportPublic FDA data

VyPlate™

Primary DI
00840283401817
Brand
VyPlate™
Company
VY SPINE LLC
Model
06-TF-45-12-TI-N
Device description
Tapping, Fixed Screw, Ø4.5x12mm, 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
00840283401817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840283401817008402834018178402834018170840283401817

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
10888857037953EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWQ2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWQ2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24