Washer

Basic Information

• Brand Name: Washer
• Primary DI: 07613327036176
• Version / Model: 6290-8-620
• Catalog Number: 6290-8-620
• Company Name: Howmedica Osteonics Corp.
• Labeler DUNS: 058311945
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2023-11-13
• Public Version Status: Update
• Public Device Record Key: 792c4d11-6011-447d-b5c3-86e8c01c36c7
• Distribution End Date: 2016-05-24

Device Description

Vitallium Washer for Bone Screw

Device Characteristics

• Single Use: Yes
• 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: 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: 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
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327036176	GS1

Premarket Submissions

Submission Number	Supplement Number
K864633	000
K974685	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	6.2	Millimeter