FDA.reportPublic FDA data

FIREBIRD SFS

Primary DI
18257200047338
Brand
FIREBIRD SFS
Company
Orthofix US LLC
Model
52-1308
Device description
SCREW SIZING TEMPLATE
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200047338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720004733818257200047338

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
927083808
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
05055445928780SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928797SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928803SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928810SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928827SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928834SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928841SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
00850085914002IMRISeyeIMRIS Imaging, Inc.FTY2026-05-07
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
04719846011786CharderCHARDER ELECTRONIC CO., LTD.FTY2026-04-29
00190776418724MillenniumAvalign Technologies, Inc.FTY2026-04-09
00757770413607Bausch + LombBausch & Lomb IncorporatedFTY2026-03-31
00840117349827Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
00887868287510Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108027Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108034Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108041Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108058Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108065Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108096Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
00371347019841Advance Dental ProductsThe Atlanta Dental Supply CompanyFTY2025-10-02
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
04946585251672CROWNJUN Micro ScaleKONO SEISAKUSHO CO.,LTD.FTY2024-11-14
14026704920553KMEDICTELEFLEX INCORPORATEDFTY2024-07-15