Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm

FDA UDI

Class I (US FDA UDI)

by Spineup, Inc.

Identity

Trade Name: Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm FDA UDI
Generic Name: Orthopaedic implant driver FDA UDI
Device Name: Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm FDA UDI
Model / Reference: RO0036SDBJ FDA UDI
Description: Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm FDA UDI

Identifiers

Catalog Number: RO0036SDBJ FDA UDI
Primary DI / UDI-DI: B806RO0036SDBJ0 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Orthopaedic implant driver 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

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

Category: Orthopaedic implant driver

Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm by Spineup, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Spineup, Inc.

Sources (1)

FDA UDI e9e517b9-115c-4cad-9fd2-7a785ee60374 35 fields · synced May 30, 2026