LumiVy™

FDA UDI

Class II (US FDA UDI)

by Vy Spine Llc

Identity

Trade Name: LumiVy™ FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: PLIF Trial, 10x30, 6mm FDA UDI
Model / Reference: 03-ITP-1030-06 FDA UDI
Description: PLIF Trial, 10x30, 6mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00840283402364 FDA UDI
510(k) Number: K212930 FDA UDI
FDA Product Code: MAX 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Spinal implant trial

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

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ROI-A — Ldr Spine USA · Class II

Cleared under the same submission

K212930 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Vy Spine Llc

Sources (1)

FDA UDI d13401c2-cc5f-43b6-906e-269416990808 35 fields · synced May 30, 2026