ROMEO posterior osteosynthesis system

FDA UDI

Class I (US FDA UDI)

by Spineart

Identity

Trade Name: ROMEO posterior osteosynthesis system FDA UDI
Generic Name: Surgical power tool adaptor FDA UDI
Device Name: Pre bent longidunal rod lg 230Stryker Series 7 Power Adapter FDA UDI
Model / Reference: SPE-US 00 25-N FDA UDI
Description: Pre bent longidunal rod lg 230Stryker Series 7 Power Adapter FDA UDI

Identifiers

Catalog Number: SPE-US 00 25-N FDA UDI
Primary DI / UDI-DI: 07640185341067 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Surgical power tool adaptor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical power tool adaptor

ROMEO posterior osteosynthesis system by Spineart — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool adaptor.

Offset reamer handle - Large AO - Tri coupling (NL) — INCIPIO DEVICES · Class I
Offset reamer handle - Hudson motor shaft — INCIPIO DEVICES · Class I
HAMMR™ — Biomet Orthopedics, Inc. · Class I
Mod Inserter Connector — Zimmer, Inc. · Class I
Carbon offset reamer handle Harris with parking — MPS Micro Precision Systems AG · Class I
Enztec Straight Reamer Driver – Locking – Bridgeback – Hudson — ENZTEC LIMITED · Class I
HAMMR™ — Biomet Orthopedics, Inc. · Class I
Enztec ORD - Corin - Open - Zimmer — ENZTEC LIMITED · 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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Spineart

Sources (1)

FDA UDI 1bd96d68-2a7b-4c12-b1b4-6711ef0e98ae 34 fields · synced Jun 8, 2026