FDA.reportPublic FDA data

VY SPINE, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30198376783019837678VY SPINE, LLC1N2026-01-01545 West 500 South Suite 100 & 110 Bountiful UT US 84010

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840283403477LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 7mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com
00840283403484LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 8mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com
00840283403491LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 9mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com
00840283403507LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 10mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com
00840283403514LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 11mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com
00840283403521LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 12mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com
00840283403538LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 13mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com
00840283403545LumiVy™ - T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 14mm, PEEK Optima LT1 - CP Ti866-489-7746info@vyspine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2946541442914571K260697VyPlate™ Anterior Cervical Plate SystemKWQ2026-03-27
2946541967470105K253432DiversiVy™ Facet Screw SystemMRW2026-03-19
2946541341029369K242784Vy Spine™ VyLam™ Laminoplasty SystemNQW2024-10-16
2946541727627040K241783FortiVy™ OsteoVy™ Lumbar IBFMAX2025-03-18
2946541356802321K233807LumiVy™ Lumbar IBF SystemMAX2024-09-24
2946541843591784K232471Vy Spine™ VyLam™ Laminoplasty SystemNQW2023-10-10
2946541521439843K232167VySpan™ PCT SystemNKG2023-09-27
2946541090859619K231836ClariVy™ Cervical IBF SystemODP2023-10-30
2946541361102588K231744VyLink™ Spinal Screw SystemNKB2023-10-13
2946542050770110K230414ClariVy™ Cervical IBF SystemODP2023-05-12
2946541428296169K223852VySpan™ PCT SystemNKG2023-02-24
2946541080864206K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemODP2023-04-18
2946541506166221K223412LumiVy™ Lumbar IBF SystemMAX2023-01-06
2946541946658420K221572VyPlate Anterior Cervical Plate SystemKWQ2022-07-26
2946541862945756K221162UniVy OsteoVy Cervical IBF SystemODP2022-11-04
2946541951992265K213750VyLink™ Spinal Screw SystemNKB2022-02-28
2946541836942261K213394Vy Spine™ VySpan™ PCT SystemNKG2021-12-10
2946541066149693K213219Vy Spine™ VyWasher™ Buttress SystemKWQ2021-12-23
2946541539398516K212930LumiVy Lumbar IBF SystemMAX2022-02-16
2946541117868713K212715Vy Spine ClariVy Cervical IBF SystemODP2021-12-20
2946541208303575K173102Reliance Cervical IBF SystemODP2017-12-29
2946541602814279K152131Reliance Spinal Screw SystemMNI2015-09-17
2946541737311775K142867Reliance Posterior Cervical-Thoracic SystemKWP2015-04-29
2946541263266106K142269Reliance Cervical IBF SystemODP2015-06-09
2946541636596646

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ODP72023-10-30
MAX42025-03-18
KWQ32026-03-27
NKG32023-09-27
NQW22024-10-16
NKB22023-10-13
MRW12026-03-19
MNI12015-09-17
KWP12015-04-29

PMN#

GUDID#

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