FDA.reportPublic FDA data

OptiVu™ Mixed Reality

Primary DI
00887868579219
Brand
OptiVu™ Mixed Reality
Company
Orthosoft Inc
Model
OVMR-SW-2-0201
Catalog number
OVMR-SW-2-0201
Published
2023-09-07
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
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
K230567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230567000OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)2023-06-13SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868579219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868579219008878685792198878685792190887868579219

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

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
Manufacturing date on label
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
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOLO2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195560Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195577Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195584Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195591Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195607Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195614Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30