FDA.reportPublic FDA data

STELLAR Knee

Primary DI
00850046497117
Brand
STELLAR Knee
Company
POLARISAR, INC.
Model
Revision 01
Catalog number
80-0004
Device description
Kit, Head Mounted Device
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850046497117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046497117008500464971178500464971170850046497117

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

Regulatory Flags#

DUNS number
035071717
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046497179STELLAR Knee Marker Kit80-000680-00062025-06-16
00850046497186TruFix Pin Kit80-000580-00052025-06-16
00850046497193Right Femur - Left Tibia Arm Assembly50-001450-00142025-06-16
00850046497209Left Femur - Right Tibia Arm Assembly50-001550-00152025-06-16
00850046497001STELLAR KneeRevision 0380-00012025-03-03
00850046497018STELLAR KneeRevision 0380-00022025-03-03
00850046497025STELLAR KneeRevision 0080-00032025-03-03
00850046497032STELLAR KneeRevision 0150-00052025-03-03
00850046497049STELLAR KneeRevision 0230-00162025-03-03
00850046497056STELLAR KneeRevision 0230-00172025-03-03
00850046497063STELLAR KneeRevision 0230-00202025-03-03
00850046497070STELLAR KneeRevision 0130-00212025-03-03
00850046497087STELLAR KneeRevision 0130-00222025-03-03
00850046497100STELLAR KneeSoftware Version 1.2.270-00012025-03-03
00850046497124STELLAR KneeRevision 0080-0004-STREAM2025-03-03
00850046497131STELLAR KneeSoftware Version 2.0.10770-00032025-03-03
00850046497148STELLAR KneeRevision 0180-00072025-03-03
00850046497155STELLAR KneeRevision 0180-0007-STREAM2025-03-03
00850046497162STELLAR KneeRevision 0180-0007-OBSERVER2025-03-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
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00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08