Restoration

Basic Information

• Brand Name: Restoration
• Primary DI: 07613327017724
• Version / Model: 2083-0068
• Catalog Number: 2083-0068
• 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: 4
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 0442032c-5d15-433e-8bcf-48e0ddbbfb96

Device Description

Acetabular Shell w/ Scr Hls

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
JDJ	Mesh, surgical, acetabular, hip, prosthesis	General, Plastic Surgery	878.3300	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327017724	GS1

Premarket Submissions

Submission Number	Supplement Number
K970957	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	68.0	Millimeter