Restoration

Basic Information

• Brand Name: Restoration
• Primary DI: 07613327019797
• Version / Model: 5096-5815
• Catalog Number: 5096-5815
• 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: 2022-08-01
• Public Version Status: Update
• Public Device Record Key: 433a1966-6efb-49cb-bfeb-0e40a262f78e

Device Description

Acetabular Wedge Augment

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: MR Conditional
• 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
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60516	Metallic acetabulum prosthesis	A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327019797	GS1

Premarket Submissions

Submission Number	Supplement Number
K102019	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	60.0	Millimeter
Device Size Text, specify			Thickness: 15.0 Millimeter
Outer Diameter	58.0	Millimeter