ROMERO CERVICAL CAGE, W18xD12xH13

FDA UDI

Class II (US FDA UDI)

by Spineup, Inc.

Identity

Trade Name: ROMERO CERVICAL CAGE, W18xD12xH13 FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti -6Al-4V ELI) fixation screws for cages with screw holes. FDA UDI
Model / Reference: ISRO1218L13CB1 FDA UDI
Description: The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti -6Al-4V ELI) fixation screws for cages with screw holes. FDA UDI

Identifiers

Catalog Number: ISRO1218L13CB1 FDA UDI
Primary DI / UDI-DI: ISRO1218L13CB1 FDA UDI
FDA Product Code: OVE FDA UDI
ODP FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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Single Use

Yes

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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

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

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Dimensions & Sizes

Size: Width — 18 Millimeter FDA UDI
Depth — 12 Millimeter FDA UDI
Height — 13 Millimeter FDA UDI
Angle — 6 degree FDA UDI

Category: Polymeric spinal interbody fusion cage

The Romero Cervical Cage is a cutting-edge, innovative cervical cage designed to provide optimal spinal stability and promote osseointegration for degenerative disc disease (DDD) treatment. Made from durable, non-bioabsorbable PEEK interbody cages with radiographic markers, this device offers unparalleled support and fixation, allowing patients to achieve long-lasting results.

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 II	Pending data

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Manufacturer

Manufacturer: Spineup, Inc.

Sources (1)

FDA UDI b6488986-2658-4a5c-8928-6ce199e80311 36 fields · synced Jul 25, 2026