FDA.reportPublic FDA data

ROSA® KNEE PERSONA® ID PLATE

Primary DI
00889024516809
Brand
ROSA® KNEE PERSONA® ID PLATE
Company
Orthosoft Inc
Model
20-8020-060-01
Catalog number
20-8020-060-01
Published
2019-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
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
00889024516809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024516809008890245168098890245168090889024516809

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, reusableA label or a tag intended to indicate the operating/calibration status (e.g., calibrated, repair required, out of service) and/or sterility record of the device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed to a specific standard. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00889024673403NavitrackER®20-8087-000-0020-8087-000-002026-06-26
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
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13