HARRIER™ Choice Spine Intervertebral Body Device

FDA UDI

Class II (US FDA UDI)

by Choicespine, LP

Identity

Trade Name: HARRIER™ Choice Spine Intervertebral Body Device FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: HARRIER,SPACER,ALIF,26x20x14,6 DEG FDA UDI
Model / Reference: JP10-26200614 FDA UDI
Description: HARRIER,SPACER,ALIF,26x20x14,6 DEG FDA UDI

Identifiers

Primary DI / UDI-DI: 00840996140423 FDA UDI
510(k) Number: K153107 FDA UDI
FDA Product Code: MAX FDA UDI
MQP FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Category: Polymeric spinal interbody fusion cage

HARRIER™ Choice Spine Intervertebral Body Device by Choicespine, LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

K153107 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: Choicespine, LP

Sources (1)

FDA UDI 0fca1802-fb7d-45ea-ae9c-148572c631ed 35 fields · synced Jun 8, 2026