510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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VY Spine, LLC

Bountiful, UT, US

VY SPINE, LLC appears in FDA device records in Bountiful, UT. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 21 510(k) clearances for VY Spine, LLC between 2021 and 2026. The busiest year on record is 2023, with 8. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for VY Spine, LLC, by decision year
YearClearances
20213
20224
20238
20242
20251
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260697VyPlate™ Anterior Cervical Plate SystemKWQSubstantially Equivalent
K253432DiversiVy™ Facet Screw SystemMRWSubstantially Equivalent
K253158VyBrate™ VBR SystemMQPSubstantially Equivalent
K241783FortiVy™ OsteoVy™ Lumbar IBFMAXSubstantially Equivalent
K242784Vy Spine™ VyLam™ Laminoplasty SystemNQWSubstantially Equivalent
K233807LumiVy™ Lumbar IBF SystemMAXSubstantially Equivalent
K231836ClariVy™ Cervical IBF SystemODPSubstantially Equivalent
K231744VyLink™ Spinal Screw SystemNKBSubstantially Equivalent
K232471Vy Spine™ VyLam™ Laminoplasty SystemNQWSubstantially Equivalent
K232167VySpan™ PCT SystemNKGSubstantially Equivalent
K230414ClariVy™ Cervical IBF SystemODPSubstantially Equivalent
K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemODPSubstantially Equivalent
K223852VySpan™ PCT SystemNKGSubstantially Equivalent
K223412LumiVy™ Lumbar IBF SystemMAXSubstantially Equivalent
K221162UniVy OsteoVy Cervical IBF SystemODPSubstantially Equivalent
K221572VyPlate Anterior Cervical Plate SystemKWQSubstantially Equivalent
K213750VyLink™ Spinal Screw SystemNKBSubstantially Equivalent
K212930LumiVy Lumbar IBF SystemMAXSubstantially Equivalent
K213219Vy Spine™ VyWasher™ Buttress SystemKWQSubstantially Equivalent
K212715Vy Spine ClariVy Cervical IBF SystemODPSubstantially Equivalent
K213394Vy Spine™ VySpan™ PCT SystemNKGSubstantially Equivalent

Registered establishments

FDA registered establishments for VY Spine, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30198376783019837678VY SPINE, LLC545 West 500 South, Bountiful, UT 84010 US2026and 5 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain