FDA.reportPublic FDA data

ROSA® Shoulder

Primary DI
00889024699809
Brand
ROSA® Shoulder
Company
Orthosoft Inc
Model
20-8087-150-02
Catalog number
20-8087-150-02
Published
2026-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K260582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260582000ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-05-21OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024699809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024699809008890246998098890246998090889024699809

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). 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@zimmer.com

Regulatory Flags#

DUNS number
205670032
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00887868554391Signature™ Comprehensive®20-8090-009-0120-8090-009-012024-02-09
00887868554407Signature™ Comprehensive®20-8090-009-0220-8090-009-022024-02-09
00887868552205ROSA® Knee20-8020-191-0020-8020-191-002022-10-20
00889024563636Sesamoid ®20-8000-000-1120-8000-000-112021-01-28
00889024304079Trabecular Metal20-8075-004-0220-8075-004-022016-09-12
00889024304307ROSA® Robotics20-8000-010-0620-8000-010-062016-09-07
00889024304406ROSA® Robotics20-8000-010-1720-8000-010-172016-09-07
00889024304413Optical20-8000-010-1820-8000-010-182016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
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
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22