FDA.reportPublic FDA data

ROSA® KNEE SOFTWARE UPGRADE

Primary DI
00889024511347
Brand
ROSA® KNEE SOFTWARE UPGRADE
Company
Orthosoft Inc
Model
20-8020-140-01
Catalog number
20-8020-140-01
Published
2019-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182964000ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)2019-01-24OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024511347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024511347008890245113478890245113470889024511347

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation system application softwareAn individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868552113Signature ONE Software Package302.40182026-10-27
00887868578922ROSA® Knee20-8020-130-012026-10-27
00887868578939ROSA Partial Knee Software20-8020-150-012026-10-27
00887868581090ROSA® Robotics20-8020-028-002026-10-27
00887868581106ROSA® Robotics20-8020-029-002026-10-27
00889024305533iASSIST20-8011-070-042026-10-27
00889024305557iASSIST20-8011-070-082026-10-27
00889024671270ROSA® Hip20-8060-400-012026-10-27
00887868573040Sesamoid® System20-8000-000-012026-10-26
00887868573057Sesamoid® System20-8000-000-022026-10-26
00887868579608ROSA® Robotics20-8000-010-062026-10-26
00887868579615ROSA® Robotics20-8000-010-172026-10-26
00887868579622ROSA® Robotics20-8000-010-332026-10-26
00887868579639ROSA® Robotics20-8000-010-352026-10-26
00887868579646ROSA® Robotics20-8000-010-362026-10-26
00889024705999Navitracker20-8000-070-052026-10-26
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00887868552120ROSA®20-8020-158-0020-8020-158-002023-04-10
00887868558146ROSA® Shoulder20-8087-302-00208087302002024-03-06
00887868580963ROSA® Shoulder20-8087-506-00208087506002024-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337118985J-Needle Navi WL 120, trocar, 11 GJoimax GmbHOLO2026-10-28
00887868578922ROSA® KneeOrthosoft IncOLO2026-10-27
00887868578939ROSA Partial Knee SoftwareOrthosoft IncOLO2026-10-27
00887868581090ROSA® RoboticsOrthosoft IncOLO2026-10-27
00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
00889024671270ROSA® HipOrthosoft IncOLO2026-10-27
04056481145323Patient Reference Carbon-Clamp Spine & TraumaBrainlab SEOLO2026-10-27
04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
04056481148225Sterilization Tray Accessories Spine MISBrainlab SEOLO2026-10-27
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26
00887868573040Sesamoid® SystemOrthosoft IncOLO2026-10-26
00887868573057Sesamoid® SystemOrthosoft IncOLO2026-10-26
00887868579608ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579615ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579622ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579639ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579646ROSA® RoboticsOrthosoft IncOLO2026-10-26
00889024705999NavitrackerOrthosoft IncOLO2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-23
04056481146207Spine PlanningBrainlab SEOLO2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22