FDA.reportPublic FDA data

STELLAR Knee

Primary DI
00850046497049
Brand
STELLAR Knee
Company
POLARISAR, INC.
Model
Revision 02
Catalog number
30-0016
Device description
DISTAL FEMUR RESECTION BLOCK
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
00850046497049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046497049008500464970498500464970490850046497049

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
035071717
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
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
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
00850046497117STELLAR KneeRevision 0180-00042025-03-03
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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