RESTORIS 170505

GUDID 00848486003500

MCK FEMORAL TRIAL (SIZE 5 LM/RL)

MAKO SURGICAL CORP.

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Primary Device ID00848486003500
NIH Device Record Key50695430-f8c0-4978-af1b-e82d677ccfa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESTORIS
Version Model Number170505
Catalog Number170505
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100848486003500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

Moist Heat or Steam Sterilization


[00848486003500]

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 [RESTORIS]

00848486023508FEMORAL 1.75 INCH HEADED PIN
00848486023461MCK PATELLA SIZING GUIDE (38mm/41mm)
00848486023454MCK PATELLA SIZING GUIDE (26mm/29mm)
00848486022013OFFSET CUP IMPACTOR
00848486021870STRAIGHT CUP IMPACTOR
00848486021641HIP OFFSET CUP IMPACTOR (TJO)
00848486020644MCK ONLAY INSERT EXTRACTOR
00848486020378MCK PATELLA RESECTION CLAMP
00848486020323MCK PEG DRILL (FEMORAL)
00848486020316MCK GOELET RETRACTOR
00848486020309MCK FEMORAL TEMPLATE (SIZE 7 RM/LL)
00848486020293MCK FEMORAL TEMPLATE (SIZE 6 RM/LL)
00848486020286MCK FEMORAL TEMPLATE (SIZE 5 RM/LL)
00848486020279MCK FEMORAL TEMPLATE (SIZE 4 RM/LL)
00848486020262MCK FEMORAL TEMPLATE (SIZE 3 RM/LL)
00848486020255MCK FEMORAL TEMPLATE (SIZE 2 RM/LL)
00848486020248MCK FEMORAL TEMPLATE (SIZE 1 RM/LL)
00848486020231MCK FEMORAL TEMPLATE (SIZE 8 LM/RL)
00848486020224MCK FEMORAL TEMPLATE (SIZE 7 LM/RL)
00848486020217MCK FEMORAL TEMPLATE (SIZE 6 LM/RL)
00848486020200MCK FEMORAL TEMPLATE (SIZE 5 LM/RL)
00848486020194MCK FEMORAL TEMPLATE (SIZE 4 LM/RL)
00848486020187MCK FEMORAL TEMPLATE (SIZE 3 LM/RL)
00848486020170MCK FEMORAL TEMPLATE (SIZE 2 LM/RL)
00848486020163MCK FEMORAL TEMPLATE (SIZE 1 LM/RL)
00848486020156Tibial Baseplate Template Std RM/LL Sz8
00848486020149MCK BASEPLATE TEMPLATE (SIZE 7 RM/LL)
00848486020132MCK BASEPLATE TEMPLATE (SIZE 6 RM/LL)
00848486020125MCK BASEPLATE TEMPLATE (SIZE 5 RM/LL)
00848486020118MCK BASEPLATE TEMPLATE (SIZE 4 RM/LL)
00848486020101Tibial Baseplate Template Std RM/LL Sz3
00848486020095MCK BASEPLATE TEMPLATE (SIZE 2 RM/LL)
00848486020088MCK BASEPLATE TEMPLATE (SIZE 1 RM/LL)
00848486020071MCK BASEPLATE TEMPLATE (SIZE 7 LM/RL)
00848486020064MCK BASEPLATE TEMPLATE (SIZE 6 LM/RL)
00848486020057MCK BASEPLATE TEMPLATE (SIZE 5 LM/RL)
00848486020040MCK BASEPLATE TEMPLATE (SIZE 4 LM/RL)
00848486020033MCK BASEPLATE TEMPLATE (SIZE 3 LM/RL)
00848486020026MCK BASEPLATE TEMPLATE (SIZE 2 LM/RL)
00848486020019MCK PF TEMPLATE (8 RIGHT)
00848486020002MCK PF TEMPLATE (7 RIGHT)
00848486019990MCK PF TEMPLATE (6 RIGHT)
00848486019983MCK PF TEMPLATE (5 RIGHT)
00848486019976MCK PF TEMPLATE (4 RIGHT)
00848486019969MCK PF TEMPLATE (3 RIGHT)
00848486019952MCK PF TEMPLATE (2 RIGHT)
00848486019945MCK PF TEMPLATE (8 LEFT)
00848486019938MCK PF TEMPLATE (7 LEFT)
00848486019921MCK PF TEMPLATE (6 LEFT)
00848486019914MCK PF TEMPLATE (5 LEFT)

Trademark Results [RESTORIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESTORIS
RESTORIS
77382822 3522351 Live/Registered
MAKO Surgical Corp.
2008-01-29

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