FDA.reportPublic FDA data

Firebird SI Navigation System

Primary DI
18257200164950
Brand
Firebird SI Navigation System
Company
Orthofix US LLC
Model
18-1912
Device description
12mm 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
18257200164950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720016495018257200164950

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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
18257200066421Orthofix Proview70-23002016-07-14
18257200066438Orthofix Proview70-23012016-07-14
18257200066445Orthofix Proview70-23022016-07-14
18257200066452Orthofix Proview70-23032016-07-14
28257200066497Orthofix Proview70-23042016-07-14
00850071315226TrendDCT-0180DCT-01802026-04-25
00850071315264TrendDCT-3951DCT-39512026-04-25
00850071315295TrendDCT-6061T-2DCT-6061T-22026-04-25
00850071315301TrendDCT-6061T-3DCT-6061T-32026-04-25
00850071315332TrendDCT-6061S-2DCT-6061S-22026-04-25
00850071315356TrendDCT-6061S-4DCT-6061S-42026-04-25
00850071315370TrendDCT-1971-2DCT-1971-22026-04-25
00850071315387TrendDCT-1971-4DCT-1971-42026-04-25
00850071315400TrendDCT-908-RDCT-908-R2026-04-25
00850071315417TrendDCT-908-LDCT-908-L2026-04-25
00850071315448TrendDCT-200-RDCT-200-R2026-04-25
00850071315455TrendDCT-200-LDCT-200-L2026-04-25
00850071315509TrendVSL-747-LGVSL-747-LG2026-04-25
00850071315516TrendDCT-3960DCT-39602026-04-25
00850071315462TrendDCT-1516-RDCT-1516-R2026-04-23

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