FDA.reportPublic FDA data

ROSA® Shoulder

Primary DI
00887868558283
Brand
ROSA® Shoulder
Company
Orthosoft Inc
Model
20-8087-501-00
Catalog number
20808750100
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, image processing, radiological
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233199000ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)2024-02-21OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868558283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868558283008878685582838878685582830887868558283

GMDN Terms#

Term, Definition table
TermDefinition
Sensor holder, reusableA device designed to hold (house) a sensor so that it is fixed (locked) in a stable position. This device will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body during computer assisted surgery (CAS), another device, or a suitable place in the vicinity of use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)336-7846zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
205670032
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024673403NavitrackER®20-8087-000-0020-8087-000-002026-06-26
00887868554391Signature™ Comprehensive®20-8090-009-0120-8090-009-012024-02-09
00887868554407Signature™ Comprehensive®20-8090-009-0220-8090-009-022024-02-09
00887868579219OptiVu™ Mixed RealityOVMR-SW-2-0201OVMR-SW-2-02012023-09-07
00887868579226OptiVu™ Mixed RealityOVMR-SW-2-0202OVMR-SW-2-02022023-09-07
00887868554483OptiVu™ Mixed RealityOVMR-SW-2-0005OVMR-SW-2-00052023-03-31
00887868554490OptiVu™ Mixed RealityOVMR-SW-2-0006OVMR-SW-2-00062023-03-31
00887868519017iASSIST® Knee System20-8011-501-0020-8011-501-002022-11-15
00887868519130iASSIST® Knee System20-8000-070-0220-8000-070-022022-11-14
00887868519154iASSIST® Knee System20-8011-063-0020-8011-063-002022-11-14
00887868519161iASSIST® Knee System20-8011-065-0020-8011-065-002022-11-14
00887868540509iASSIST® Knee System20-8011-501-002022-10-17
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00887868557590X-PSI Knee803.308803.3082022-08-11
00887868557606PSI Knee803.302803.3022022-08-11
00887868522987Signature ONE20-8090-008-012022-07-20
00887868522994Signature ONE20-8090-008-022022-07-20
00887868523106ONE Planner HipCG200CG2002021-07-28
00889024563643iASSIST®20-8000-000-2020-8000-000-202021-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
00889024713390ROSA® ShoulderOrthosoft IncOLO2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
00885556919781Real IntelligenceSmith & Nephew, Inc.OLO2026-10-13
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
09421904268333Volpara ScorecardLUNIT INTERNATIONAL LIMITEDLLZ2025-05-06
04056481144906Spine &Trauma NavigationBrainlab SEOLO2024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMABrainlab SEOLO2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMPBrainlab SEOLO2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAYBrainlab SEOLO2024-11-14
04056481144753Drill Guide ArrayBrainlab SEOLO2024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)Brainlab SEOLO2024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)Brainlab SEOLO2024-06-04
04056481144784Drill Guide Tube (4.5 mm)Brainlab SEOLO2024-06-04