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
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
00889024478961Camera Kit20-8000-070-9920-8000-070-992016-12-21
00889024478978Sesamoid Plasty V2 Computer Kit20-8000-070-7720-8000-070-772016-12-21
00889024485518AC power cord North America20-8000-070-7120-8000-070-712016-12-21
00889024488502Sesamoid Plasty V2 HDMI Cable 30'20-8000-071-242017-04-10
00889024492752NA20-8000-070-212017-09-12
00889024492769NA20-8000-070-462017-09-12
00889024511026ROSA® Recon Platform20-8020-100-0120-8020-100-012019-03-06
00889024511170ROSA® Recon20-8020-110-0120-8020-110-012019-03-06
00889024511323ROSA® KNEE OPTICAL UNIT20-8020-120-0120-8020-120-012019-03-06

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