ROMEO posterior osteosynthesis system

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name: ROMEO posterior osteosynthesis system FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: SCREWDRIVER SHAFT PS CANNULATED. NAV. FDA UDI
Model / Reference: MIS-NV 02 00-N FDA UDI
Description: SCREWDRIVER SHAFT PS CANNULATED. NAV. FDA UDI

Identifiers

Catalog Number: MIS-NV 02 00-N FDA UDI
Primary DI / UDI-DI: 07640178972322 FDA UDI
FDA Product Code: KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3070 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

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Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

The ROMEO posterior osteosynthesis system is a non-powered, reusable screwdriver shaft cannulated device used for anterior-posterior rotational or translational application in orthopedic and dental surgical procedures. It offers flexibility in connection/disconnection to other devices attached to patients, making it suitable for various medical specialties.

Similar devices

Also classified as Surgical screwdriver, reusable.

Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
KLOCKNER — SOADCO, S.L. · Class I

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: Spineart

Sources (1)

FDA UDI 895b7f35-c083-40a9-86b5-6906e291caf5 34 fields · synced Jul 14, 2026