FDA.reportPublic FDA data

OptiVu Shoulder Tracker Kit

Primary DI
00850084604119
Brand
OptiVu Shoulder Tracker Kit
Company
MR Surgical Solutions LLC
Model
OVMRHL2-010
Device description
Trackers used to register and optically track anatomy and instruments in real time
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252530000OptiVu™ ShoulderMr Surgical Solutions, LLC2025-09-10SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850084604119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850084604119008500846041198500846041190850084604119

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Contacts#

Phone, Email table
PhoneEmail
+41445525264admin@fixsurgical.com

Regulatory Flags#

DUNS number
144964858
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850084604003OptiVu Shoulder Adapter HandleOVMR-HW-2-03122026-06-03
00850084604010OptiVu Shoulder Pin InserterOVMR-HW-2-03202026-06-03
00850084604027OptiVu Shoulder Cut GuideOVMR-HW-2-03212026-06-03
00850084604034OptiVu Shoulder StylusOVMR-HW-2-03242026-06-03
00850084604041OptiVu Shoulder Reaming GuideOVMR-HW-2-03282026-06-03
00850084604058OptiVu Shoulder Clocking GuideOVMR-HW-2-03442026-06-03
00850084604065OptiVu Shoulder Humeral Reference RodOVMR-HW-2-03342026-06-03
00850084604072OptiVu Shoulder Scapular Reference RodOVMR-HW-2-03312026-06-03
00850084604089OptiVu Shoulder Sterile TrayOVMR-TR-2-00012026-06-03
00850084604096OptiVu Shoulder Software ApplicationOVMR-SW-2-03102026-06-03
00850084604102OptiVu Shoulder Humeral GaugeOVMR-HW-2-03222026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinOVMRHL2-0122026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084604003OptiVu Shoulder Adapter HandleMR Surgical Solutions LLCSBF2026-06-03
00850084604010OptiVu Shoulder Pin InserterMR Surgical Solutions LLCSBF2026-06-03
00850084604027OptiVu Shoulder Cut GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604034OptiVu Shoulder StylusMR Surgical Solutions LLCSBF2026-06-03
00850084604041OptiVu Shoulder Reaming GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604058OptiVu Shoulder Clocking GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604065OptiVu Shoulder Humeral Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604072OptiVu Shoulder Scapular Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604089OptiVu Shoulder Sterile TrayMR Surgical Solutions LLCSBF2026-06-03
00850084604096OptiVu Shoulder Software ApplicationMR Surgical Solutions LLCSBF2026-06-03
00850084604102OptiVu Shoulder Humeral GaugeMR Surgical Solutions LLCSBF2026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinMR Surgical Solutions LLCSBF2026-06-03
03760297030490KneePlusPIXEE MEDICALSBF2026-05-27
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