ACCOLADE II 210433-3227

GUDID 00848486028091

132¿ 27mm NECK TRIAL

MAKO SURGICAL CORP.

Femoral stem prosthesis trial
Primary Device ID00848486028091
NIH Device Record Key56e6923e-50c7-471e-8793-93aa2b6d31cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCOLADE II
Version Model Number210433-3227
Catalog Number210433-3227
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length27 Millimeter
Length27 Millimeter
Device Size Text, specify0
Length27 Millimeter
Device Size Text, specify0
Length27 Millimeter
Device Size Text, specify0
Length27 Millimeter
Device Size Text, specify0
Length27 Millimeter
Device Size Text, specify0
Length27 Millimeter
Device Size Text, specify0
Length27 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486028091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486028091]

Moist Heat or Steam Sterilization


[00848486028091]

Moist Heat or Steam Sterilization


[00848486028091]

Moist Heat or Steam Sterilization


[00848486028091]

Moist Heat or Steam Sterilization


[00848486028091]

Moist Heat or Steam Sterilization


[00848486028091]

Moist Heat or Steam Sterilization


[00848486028091]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-24

On-Brand Devices [ACCOLADE II]

00848486028138132¿ 40mm NECK TRIAL
00848486028121132¿ 37mm NECK TRIAL
00848486028114132¿ 35mm NECK TRIAL
00848486028107132¿ 30mm NECK TRIAL
00848486028091132¿ 27mm NECK TRIAL
00848486028084127¿ 40mm NECK TRIAL
00848486028077127¿ 37mm NECK TRIAL
00848486028060127¿ 35mm NECK TRIAL
00848486028053127¿ 30mm NECK TRIAL
00848486028046127¿ 27mm NECK TRIAL

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