ROMERO Self Tapping Screw, D3.5xL12mm

FDA UDI

Class II (US FDA UDI)

by Spineup, Inc.

Identity

Trade Name: ROMERO Self Tapping Screw, D3.5xL12mm 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: ISRO35T12SC2 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: ISRO35T12SC2 FDA UDI
Primary DI / UDI-DI: ISRO35T12SC2 FDA UDI
FDA Product Code: ODP FDA UDI
OVE 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

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

Yes

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.5 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI

Category: Polymeric spinal interbody fusion cage

ROMERO Self Tapping Screw, D3.5xL12mm by Spineup, Inc. — 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

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 d3a78c83-0313-4b62-b128-d85716d7a825 36 fields · synced May 31, 2026