Octane Straight Intervertebral Fusion Device

FDA UDI

Class I (US FDA UDI)

by Choicespine, LP

Identity

Trade Name: Octane Straight Intervertebral Fusion Device FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: OCTANE, STD PADDLE SCRAPER, 10MM FDA UDI
Model / Reference: SK-009584-10 FDA UDI
Description: OCTANE, STD PADDLE SCRAPER, 10MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00840996157360 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage 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

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Implantable

Yes

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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

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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

Category: Polymeric spinal interbody fusion cage

The Octane Straight Intervertebral Fusion Device is a high-performance, non-ablative intervertebral fusion device designed for the treatment of degenerative disc disease. This implantable spinal solution provides mechanical stability and sufficient space for therapeutic bone fusion to occur, typically in conjunction with bone grafting. The device features a unique porous design that promotes osseointegration, while its fixation screws and associated devices facilitate safe implantation.

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

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 bcb53974-a483-4fdd-9735-955980e96203 34 fields · synced Jul 22, 2026