RESTORIS PST 188615

GUDID 00848486016234

Porous Tibial Baseplate

MAKO SURGICAL CORP.

Coated unicondylar knee tibia prosthesis
Primary Device ID00848486016234
NIH Device Record Key1c49534a-8eaa-4c61-ac2c-cbc337ef915d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESTORIS PST
Version Model Number188615
Catalog Number188615
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 Identifiers

Device Issuing AgencyDevice ID
GS100848486016234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJDPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER

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 Date2015-12-11

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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