FDA.reportPublic FDA data

ROSA® Shoulder

Primary DI
00887868575136
Brand
ROSA® Shoulder
Company
Orthosoft Inc
Model
20-8087-129-00
Catalog number
20808712900
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
00887868575136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868575136008878685751368878685751360887868575136

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. 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
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00889024699762ROSA® Shoulder20-8087-142-0020-8087-142-002026-06-26
00889024699779ROSA® Shoulder20-8087-141-0020-8087-141-002026-06-26
00889024699786ROSA® Shoulder20-8087-150-0120-8087-150-012026-06-26
00889024699793ROSA® Shoulder20-8087-151-0020-8087-151-002026-06-26
00889024699809ROSA® Shoulder20-8087-150-0220-8087-150-022026-06-26
00889024699816ROSA® Shoulder20-8087-150-0320-8087-150-032026-06-26
00889024699823ROSA® Shoulder20-8087-140-0020-8087-140-002026-06-26
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00889024211605NA302.4002302.40022016-09-14
00889024211636iASSIST302.4001302.40012016-09-14
00889024305083Sesamoid20-8000-070-3520-8000-070-352016-09-12
00889024305090Sesamoid20-8000-070-3620-8000-070-362016-09-12
00889024305106Sesamoid20-8000-070-3720-8000-070-372016-09-12
00889024305113Sesamoid20-8000-070-3820-8000-070-382016-09-12
00889024305120Sesamoid20-8000-070-3920-8000-070-392016-09-12
00889024305205Sesamoid20-8000-070-6420-8000-070-642016-09-12
00889024478954Sesamoid Plasty V2 Stand20-8000-070-8020-8000-070-802016-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034648194VELYSMedos International SàrlOLO2026-10-09
10705034648200VELYSMedos International SàrlOLO2026-10-09
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00810055525225Onyx 4.5 mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525232Onyx 5.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525720Onyx Navigated Locking DriverSi-Bone Inc.OLO2026-09-30
00810055525966Onyx Navigated Locking Driver, CannulatedSi-Bone Inc.OLO2026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mmSi-Bone Inc.OLO2026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mmSi-Bone Inc.OLO2026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mmSi-Bone Inc.OLO2026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mmSi-Bone Inc.OLO2026-09-30
00810055526321Onyx iGPS DriverSi-Bone Inc.OLO2026-09-30
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25