FDA.reportPublic FDA data

FIREBIRD NXG POCT,NAVIGATED INSTRUMENTS

Primary DI
18257200140633
Brand
FIREBIRD NXG POCT,NAVIGATED INSTRUMENTS
Company
Orthofix US LLC
Model
36-1921
Device description
CANNULATED AWL, NAVIGATED BL
Published
2026-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K172115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172115000Navigated Instrument SystemOrthofix, Inc.2018-03-08OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200140633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720014063318257200140633

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
18257200029853FIREBIRD SFS301100262026-07-17
18257200029860FIREBIRD SFS301100272026-07-17
18257200029877FIREBIRD SFS301100282026-07-17
18257200029884FIREBIRD SFS301100292026-07-17
18257200029945FIREBIRD SFS301100352026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000914035Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914042Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914059Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914066Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914073Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914080Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000953805Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
18257200140367NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140374NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140381NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140398NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140404NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140411NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140428NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140435NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140442NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140459NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140466NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140473NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140527FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140534FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140558FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140565FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140572FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140596FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140602FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140619FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140626FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140657FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140664FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17