ROMEO posterior osteosynthesis system

Basic Information

• Brand Name: ROMEO posterior osteosynthesis system
• Primary DI: 07640185341869
• Version / Model: SPE-US 00 50-N
• Catalog Number: SPE-US 00 50-N
• Company Name: SpineArt SA
• Labeler DUNS: 483016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-01
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: c3ef4bac-cd04-4622-a5ce-bfabb9f3d3cd

Device Description

Powerease Tap, Ø7mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWX	Tap, Bone	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17507	Bone tap, reusable	A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640185341869	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	7	Millimeter