RESTORIS XLVE 186436-62

GUDID 00848486009106

Acetabular Liner, Elevated

MAKO SURGICAL CORP.

Non-constrained polyethylene acetabular liner
Primary Device ID00848486009106
NIH Device Record Key33be8cd3-0b20-4a72-b0f8-1dbf9fc8493c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESTORIS XLVE
Version Model Number186436-62
Catalog Number186436-62
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486009106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQHHip, semi-constrained, cemented, metal/polymer + additive, cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [RESTORIS XLVE]

00848486010164Acetabular Liner, High Wall
00848486010157Acetabular Liner, High Wall
00848486010140Acetabular Liner, High Wall
00848486010133Acetabular Liner, High Wall
00848486010126Acetabular Liner Neutral
00848486010119Acetabular Liner Neutral
00848486010102Acetabular Liner Neutral
00848486010096Acetabular Liner Neutral
00848486009250Acetabular Liner, High Wall
00848486009243Acetabular Liner, High Wall
00848486009236Acetabular Liner, High Wall
00848486009229Acetabular Liner, High Wall
00848486009212Acetabular Liner, High Wall
00848486009205Acetabular Liner, High Wall
00848486009199Acetabular Liner, High Wall
00848486009182Acetabular Liner, High Wall
00848486009175Acetabular Liner, High Wall
00848486009168Acetabular Liner, High Wall
00848486009151Acetabular Liner, High Wall
00848486009144Acetabular Liner, High Wall
00848486009137Acetabular Liner, High Wall
00848486009120Acetabular Liner, High Wall
00848486009113Acetabular Liner, Elevated
00848486009106Acetabular Liner, Elevated
00848486009090Acetabular Liner, Elevated
00848486009083Acetabular Liner, Elevated
00848486009076Acetabular Liner, Elevated
00848486009069Acetabular Liner, Elevated
00848486009052Acetabular Liner, Elevated
00848486009045Acetabular Liner, Elevated
00848486009038Acetabular Liner, Elevated
00848486009021Acetabular Liner, Elevated
00848486009014Acetabular Liner, Elevated
00848486009007Acetabular Liner, Elevated
00848486008994Acetabular Liner, Elevated
00848486008987Acetabular Liner
00848486008970Acetabular Liner, High Wall
00848486008963Acetabular Liner, High Wall
00848486008956Acetabular Liner, High Wall
00848486008949Acetabular Liner, High Wall
00848486008932Acetabular Liner, High Wall
00848486008925Acetabular Liner, High Wall
00848486008918Acetabular Liner, High Wall
00848486008901Acetabular Liner, High Wall
00848486008895Acetabular Liner, High Wall
00848486008888Acetabular Liner, High Wall
00848486008871Acetabular Liner, High Wall
00848486008864Acetabular Liner, High Wall
00848486008857Acetabular Liner, High Wall
00848486008840Acetabular Liner, High Wall

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