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ClariVy™

FDA UDI

Class II (US FDA UDI)

by Vy Spine Llc

Identity

Trade Name
ClariVy™ FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
IBF Trial, 14x11, 4mm FDA UDI
Model / Reference
02-IT-1411-04 FDA UDI
Description
IBF Trial, 14x11, 4mm FDA UDI

Identifiers

Primary DI / UDI-DI
00840283400254 FDA UDI
510(k) Number
K212715 FDA UDI
FDA Product Code
OVE FDA UDI
ODP FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Spinal implant trial

ClariVy™ by Vy Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K212715 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vy Spine Llc

Sources (1)

  • FDA UDI 2db90327-b5d1-42f8-9fef-bcc0c0a86c05 35 fields · synced Jun 1, 2026