RESTORIS PST 186002-50

GUDID 00848486008352

Acetabular Shell, Cluster Hole

MAKO SURGICAL CORP.

Acetabular shell
Primary Device ID00848486008352
NIH Device Record Key8a65f452-a7f9-4327-9be2-cb3fe5b497f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESTORIS PST
Version Model Number186002-50
Catalog Number186002-50
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
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Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS100848486008352 [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 PST]

00848486016265Porous Tibial Baseplate
00848486016258Porous Tibial Baseplate
00848486016241Porous Tibial Baseplate
00848486016234Porous Tibial Baseplate
00848486016227Porous Tibial Baseplate
00848486016210Porous Tibial Baseplate
00848486016203Porous Tibial Baseplate
00848486016197Porous Tibial Baseplate
00848486016180Porous Tibial Baseplate
00848486016173Porous Tibial Baseplate
00848486016166Porous Tibial Baseplate
00848486016159Porous Tibial Baseplate
00848486016142Porous Tibial Baseplate
00848486016135Porous Tibial Baseplate
00848486016128Porous Tibial Baseplate
00848486016111Porous Tibial Baseplate
00848486008444Acetabular Shell, Cluster Hole
00848486008437Acetabular Shell, Cluster Hole
00848486008420Acetabular Shell, Cluster Hole
00848486008413Acetabular Shell, Cluster Hole
00848486008406Acetabular Shell, Cluster Hole
00848486008390Acetabular Shell, Cluster Hole
00848486008383Acetabular Shell, Cluster Hole
00848486008376Acetabular Shell, Cluster Hole
00848486008369Acetabular Shell, Cluster Hole
00848486008352Acetabular Shell, Cluster Hole
00848486008345Acetabular Shell, Cluster Hole
00848486008338Acetabular Shell, Cluster Hole
00848486008321Acetabular Shell, Cluster Hole
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