FDA.reportPublic FDA data

Left Femur - Right Tibia Arm Assembly

Primary DI
00850046497209
Brand
Left Femur - Right Tibia Arm Assembly
Company
POLARISAR, INC.
Model
50-0015
Catalog number
50-0015
Device description
For Use with 80-0006.
Published
2025-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850046497209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046497209008500464972098500464972090850046497209

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-903-6894customerservice@thinkpolaris.com

Regulatory Flags#

DUNS number
035071717
Device count
1
DM exempt
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00810180351348360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00810180351676360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00810180351683360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00810180351690360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00824846012832StealthMEDTRONIC NAVIGATION, INC.OLO2026-10-30
B432360CAS010010360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CAS010020360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CAS010030360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0023B0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0023C0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0025B0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0025C0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00190376658933Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376658940Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376659053Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29