SHARK Lumbar Spacer System

FDA UDI

Class I (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,9,22X7,4 DEG FDA UDI
Model / Reference: PT22-22074 FDA UDI
Description: PLI,SPACER,SHARK,Ti,9,22X7,4 DEG FDA UDI

Identifiers

Primary DI / UDI-DI: 00840996160315 FDA UDI
FDA Product Code: MPQ FDA UDI
MAX FDA UDI
GMDN Term: Metallic spinal fusion cage, non-sterile FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size: Length — 22 Millimeter FDA UDI
Height — 7 Millimeter FDA UDI

Category: Metallic spinal fusion cage, non-sterile

SHARK Lumbar Spacer System by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
TraXis® — ZIMMER SPINE, INC. · Class II
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 I	Pending data

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Manufacturer

Manufacturer: Choicespine, LP

Sources (1)

FDA UDI 976364ae-276b-4d59-a6df-422bf85ade67 35 fields · synced Jun 8, 2026