ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS

Basic Information

• Brand Name: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
• Primary DI: 05055662917475
• Version / Model: OS465001
• Catalog Number: OS465001
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• Labeler DUNS: 218648211
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-16
• Public Version: 4
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 84d0ccd4-4ca3-4f37-97ca-8282af6c02a5

Device Description

WASHER 13.0/6.6MM FOR 4.5MM to 7.3MM CANN. SCREW

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61671	Orthopaedic bone washer, sterile	A sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055662917475	GS1
Package	05055662917406	GS1	Cardboard Box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110895	000