Lumbar Interbody Spacer Trial

FDA UDI

Class I (US FDA UDI)

by Calvary Spine, Llc

Identity

Trade Name: Lumbar Interbody Spacer Trial FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: Trial for 7mm straight lumbar inter-vertebral body spacer FDA UDI
Model / Reference: 7mm Straight FDA UDI
Description: Trial for 7mm straight lumbar inter-vertebral body spacer FDA UDI

Identifiers

Catalog Number: 310-07 FDA UDI
Primary DI / UDI-DI: B114310070 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

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

Dimensions & Sizes

Size: Height — 7 Millimeter FDA UDI

Category: Spinal implant trial

Lumbar Interbody Spacer Trial by Calvary Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Calvary Spine, Llc

Sources (1)

FDA UDI 958d8002-088d-4c00-b69c-2163cba2fdd5 36 fields · synced Jun 1, 2026