SHARK Lumbar Spacer System

FDA UDI

Class II (US FDA UDI)

by Choicespine, LP

Identity

Trade Name: SHARK Lumbar Spacer System FDA UDI
Generic Name: Metallic spinal fusion cage, non-sterile FDA UDI
Device Name: PLI,SPACER,SHARK,Ti,9,22X15,4 DEG FDA UDI
Model / Reference: PT22-22154 FDA UDI
Description: PLI,SPACER,SHARK,Ti,9,22X15,4 DEG FDA UDI

Identifiers

Primary DI / UDI-DI: 00840996160391 FDA UDI
FDA Product Code: MAX FDA UDI
MPQ FDA UDI
GMDN Term: Metallic spinal fusion cage, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
864.3260 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 22 Millimeter FDA UDI
Height — 15 Millimeter FDA UDI

Category: Metallic spinal fusion cage, non-sterile

The Shark Lumbar Spacer System is a non-sterile, disposable device designed to treat anatomical abnormalities of the vertebrae in degenerative intervertebral disks (DDD) using mechanical stability and sufficient space for therapeutic spinal bone fusion. This metallic spinal fusion cage is typically implanted between bones or bone grafts of the spine, and must be sterilized prior to use.

Similar devices

Also classified as Metallic spinal fusion cage, non-sterile.

Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
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PLIF Cage — Eisertech, LLC · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Copperhead — EMINENT SPINE LLC · Class II
SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II

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: Choicespine, LP

Sources (1)

FDA UDI fdfdaa0d-33d0-4ae1-b96e-d1d333beb8b3 35 fields · synced Jul 25, 2026