Restoration 504-02-80H-L

GUDID 07613327012651

Anatomic Hemispherical Shell

Howmedica Osteonics Corp.

Acetabular shell

Primary Device ID	07613327012651
NIH Device Record Key	e9a3e26b-2753-4b3d-be0d-e1229ccf7b88
Commercial Distribution Status	In Commercial Distribution
Brand Name	Restoration
Version Model Number	504-02-80H-L
Catalog Number	504-02-80H-L
Company DUNS	058311945
Company Name	Howmedica Osteonics Corp.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Outer Diameter	80 Millimeter
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Outer Diameter	80 Millimeter
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Outer Diameter	80 Millimeter
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Device Size Text, specify	0
Outer Diameter	80 Millimeter
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Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	80 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327012651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142462

FDA Product Code

LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

On-Brand Devices [Restoration]

07613327140927	ADM Insert
07613327140903	ADM Insert
07613327140897	ADM Insert
07613327140880	ADM Insert
07613327140873	ADM Insert
07613327140866	ADM Insert
07613327140842	ADM Insert
07613327140828	ADM Insert
07613327140804	ADM Insert
07613327140781	ADM Insert
07613327037173	Plate Screw
07613327037166	Plate Screw
07613327037159	Plate Screw
07613327037142	Plate Screw
07613327037135	Plate Screw
07613327037128	Plate Screw
07613327037111	Plate Screw
07613327037104	Plate Screw
07613327037098	Plate Screw
07613327037081	Plate Screw
07613327019872	Acetabular Wedge Augment
07613327019865	Acetabular Wedge Augment
07613327019858	Acetabular Wedge Augment
07613327019841	Acetabular Wedge Augment
07613327019834	Acetabular Wedge Augment
07613327019827	Acetabular Wedge Augment
07613327019810	Acetabular Wedge Augment
07613327019803	Acetabular Wedge Augment
07613327019797	Acetabular Wedge Augment
07613327019780	Acetabular Wedge Augment
07613327019773	Acetabular Wedge Augment
07613327019766	Acetabular Wedge Augment
07613327019759	Acetabular Wedge Augment
07613327019742	Acetabular Wedge Augment
07613327019735	Acetabular Wedge Augment
07613327019728	Acetabular Wedge Augment
07613327019711	Acetabular Wedge Augment
07613327019704	Acetabular Wedge Augment
07613327019551	Hip Stem
07613327019544	Hip Stem
07613327019537	Hip Stem
07613327019520	Hip Stem
07613327019513	Hip Stem
07613327019506	Hip Stem
07613327019490	Hip Stem
07613327019483	Hip Stem
07613327019476	Hip Stem
07613327019469	Hip Stem
07613327019452	Hip Stem
07613327019445	Hip Stem

Trademark Results [Restoration]

Mark Image Registration \| Serial	Company Trademark Application Date
RESTORATION 98754851 not registered Live/Pending	CultSkin Apothecary, Inc. 2024-09-17
RESTORATION 90460681 not registered Live/Pending	Peristyle, LLC 2021-01-12
RESTORATION 90367444 not registered Live/Pending	Mannington Mills, Inc. 2020-12-08
RESTORATION 90203068 not registered Live/Pending	TDB IP Holding, LLC 2020-09-23
RESTORATION 90060444 not registered Live/Pending	tmi 2020-07-19
RESTORATION 88935272 not registered Live/Pending	Eli Lilly and Company 2020-05-27
RESTORATION 88385654 not registered Live/Pending	Sheehan, Trevor 2019-04-15
RESTORATION 87513461 not registered Live/Pending	Restoration Skin Solutions Inc. 2017-06-30
RESTORATION 86802518 not registered Dead/Abandoned	Restoration Goods LLC 2015-10-28
RESTORATION 86045786 4475403 Live/Registered	I AM A DREAMER LLC 2013-08-22
RESTORATION 85972964 4914131 Live/Registered	Rack Room Shoes of Virginia, LLC 2013-06-28
RESTORATION 85146269 not registered Dead/Abandoned	GS FLORIDA, LLP 2010-10-06