CURVED WASHER, Ti6Al4V, 7.0 SIZE, 19mm OD

Basic Information

• Brand Name: CURVED WASHER, Ti6Al4V, 7.0 SIZE, 19mm OD
• Primary DI: 00850072364148
• Version / Model: 104-0207-09
• Company Name: ORTHO OUTCOMES, LLC
• Labeler DUNS: 133439875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-28
• Public Version: 1
• Public Version Date: 2026-03-09
• Public Version Status: New
• Public Device Record Key: 2d21ac0d-9ca6-4660-9768-cb975bc24797

Device Description

CURVED WASHER, Ti6Al4V, 7.0 SIZE, 19mm OD

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16077	Orthopaedic bone bolt	A short, implantable rod or shaft designed to be inserted through a long bone (excludes spinal bone) to secure the bone for traction or for a similar process/apparatus. The device is fastened with a nut/washer, and is typically made of metal or a polymer. It is typically used in the proximal tibia or distal femur. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850072364148	GS1