FDA.reportPublic FDA data

OptiVu Shoulder Adapter Handle

Primary DI
00850084604003
Brand
OptiVu Shoulder Adapter Handle
Company
MR Surgical Solutions LLC
Model
OVMR-HW-2-0312
Device description
Universal adapter handle for use with pin inserter and cut guide.
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850084604003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850084604003008500846040038500846040030850084604003

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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
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
00850084604119OptiVu Shoulder Tracker KitOVMRHL2-0102026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinOVMRHL2-0122026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850084604119OptiVu Shoulder Tracker KitMR Surgical Solutions LLCSBF2026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinMR Surgical Solutions LLCSBF2026-06-03
03760297030490KneePlusPIXEE MEDICALSBF2026-05-27
07630345729316NextAR TSA PlatformMedacta International SASBF2026-04-13
07630345725912NextAR Spine PlatformMedacta International SASBF2026-01-20
07630542720390NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720406NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720413NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720420NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720437NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720444NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720451NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542735448NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735455NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542714566NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714573NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714580NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714597NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714603NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542723087NextAR TSA Platform Medacta International SASBF2024-03-08