SOLAR

Basic Information

• Brand Name: SOLAR
• Primary DI: 07613327138207
• Version / Model: 5361-6107
• Catalog Number: 5361-6107
• Company Name: Howmedica Osteonics Corp.
• Labeler DUNS: 058311945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b515b411-281d-4644-b2b2-5b5bc93cd42e

Device Description

Shoulder Pegged Glenoid Component

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
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35670	Total shoulder prosthesis	A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327138207	GS1

Premarket Submissions

Submission Number	Supplement Number
K950521	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size: 7