FDA.reportPublic FDA data

Stainless Steel Tibial Nailing System

Primary DI
18032568037814
Brand
Stainless Steel Tibial Nailing System
Company
ORTHOFIX SRL
Model
1
Catalog number
74835
Device description
SOLID TIBIAL NAIL DIAMETER 8 MM LENGTH 350 MM
Published
2016-09-16
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
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18032568037814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803256803781418032568037814

GMDN Terms#

Term, Definition table
TermDefinition
Tibia nail, non-sterileA non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+039456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18053504361176TRUELOK SYSTEM154-115602018-04-28
18059015376654MINIRAL1M191-012026-05-04
18059015376661MINIRAL1M191-022026-05-04
18059015376678MINIRAL1M1912026-05-04
18059015376692PENNIG MINIFIXATOR1M444-012026-05-04
18059015376708PENNIG MINIFIXATOR1M444-022026-05-04
18059015376715PENNIG MINIFIXATOR1M4442026-05-04
18059015376784PENNIG DYNAMIC WRIST FIXATOR113761-012026-05-04
18059015376791PENNIG DYNAMIC WRIST FIXATOR113761-022026-05-04
18059015376807PENNIG DYNAMIC WRIST FIXATOR113761-032026-05-04
18059015376814PENNIG DYNAMIC WRIST FIXATOR1137612026-05-04
18054242515173Galaxy UNYCO System199-936732016-07-27
18054242515180Galaxy UNYCO System199-936702016-07-27
18052469476055ORTHOFIX MODULSYSTEM1M1462022-12-27
18052469476086ORTHOFIX MODULSYSTEM199-M1462022-12-27
18052469476406ORTHOFIX MODULSYSTEM199-M14602022-12-27
18053504369721ORTHOFIX GALAXY FIXATION SYSTEM1930402019-05-31
18053504369738ORTHOFIX GALAXY FIXATION SYSTEM1931402019-05-31
18059015375879TrueLok Elevate150-2590C2025-01-03
18059015375909TrueLok Elevate150-25052025-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982660086AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660109AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660123AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
03701037310649FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310656FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310663FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310670FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310687FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310694FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310700FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310717FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310724FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310731FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310748FLEX NAILFX SOLUTIONSHSB2021-10-26