ROSA Partial Knee Software V1.0

GUDID 00889024594036

Orthosoft Inc

Robotic surgical navigation system application software
Primary Device ID00889024594036
NIH Device Record Keya657af6d-54b4-4c6d-a1ef-bc5a033c1ee3
Commercial Distribution StatusIn Commercial Distribution
Brand NameROSA Partial Knee Software V1.0
Version Model Number20-8020-150-01
Company DUNS205670032
Company NameOrthosoft Inc
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024594036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-07
Device Publish Date2021-04-29

Devices Manufactured by Orthosoft Inc

00887868578915 - HAMMR™2024-05-01
00887868557873 - ROSA® Shoulder2024-03-14
00887868557880 - ROSA® Shoulder2024-03-14
00887868557897 - ROSA® Shoulder2024-03-14
00887868557903 - ROSA® Shoulder2024-03-14
00887868557910 - ROSA® Shoulder2024-03-14
00887868558078 - ROSA® Shoulder2024-03-14
00887868558092 - ROSA® Shoulder2024-03-14

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