FDA.reportPublic FDA data

Firebird SI Navigation System

Primary DI
18257200164936
Brand
Firebird SI Navigation System
Company
Orthofix US LLC
Model
18-1909
Device description
9mm DRILL, NAVIGATED
Published
2025-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252088000Firebird SI Navigation SystemOrthofix US, LLC2025-10-31OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200164936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720016493618257200164936

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)937-3199osi-customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200115112Collage7100052016-03-02
18257200115129Collage7100102016-03-02
18257200115136Collage7100152016-03-02
18257200121861Collage7110102016-09-14
18257200121878Collage7110152016-09-14
18257200028177PHOENIX SFS20-01012026-07-17
18257200028207PHOENIX SFS20-01202026-07-17
18257200028917FIREBIRD SFS201130732026-07-17
18257200028924FIREBIRD SFS201130742026-07-17
18257200028931FIREBIRD SFS201130752026-07-17
18257200028948FIREBIRD SFS201130762026-07-17
18257200028955FIREBIRD SFS201130782026-07-17
18257200028979FIREBIRD SFS201130802026-07-17
18257200028986FIREBIRD SFS201130812026-07-17
18257200028993FIREBIRD SFS201130822026-07-17
18257200029006FIREBIRD SFS201130832026-07-17
18257200029013FIREBIRD SFS201130842026-07-17
18257200029020FIREBIRD SFS201130852026-07-17
18257200029280FIREBIRD SFS201147972026-07-17
18257200029846FIREBIRD SFS301100252026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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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