FDA.reportPublic FDA data

LumiVy™

Primary DI
00840283402494
Brand
LumiVy™
Company
VY SPINE LLC
Model
03-IRC-3008
Device description
Lumbar Rotate Cutter, 8mm
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212930000LumiVy Lumbar IBF SystemVy Spine, LLC2022-02-16MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840283402494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840283402494008402834024948402834024940840283402494

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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