FDA.reportPublic FDA data

Syntec Femoral Nail System

Primary DI
04712782904389
Brand
Syntec Femoral Nail System
Company
SYNTEC SCIENTIFIC CORPORATION
Model
T880070N-14L
Device description
Syntec Femoral Nail System φ14 x L460mm
Published
2020-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
04712782904389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712782904389047127829043894712782904389

GMDN Terms#

Term, Definition table
TermDefinition
Femur nail, non-sterileA non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, 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

Regulatory Flags#

DUNS number
657692971
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04716873713751Syntec OS Spinal Fixation System8860088860082026-02-05
04719864661383Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020082020082026-02-05
04719864661390Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020102020102026-02-05
04719864661406Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020122020122026-02-05
04719864661413Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020142020142026-02-05
04719864661574Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040142040142026-02-05
04719864661581Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040162040162026-02-05
04719864661598Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040182040182026-02-05
04719864662830Syntec Osteo-plate and screw Fixation 2060142060142026-02-05
04719864662847Syntec Osteo-plate and screw Fixation 2060162060162026-02-05
04719864662854Syntec Osteo-plate and screw Fixation 2060182060182026-02-05
04719864679852Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2431602431602026-02-05
04719864679876Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413502413502026-02-05
04719864683736Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480502480502026-02-05
04719864683743Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480602480602026-02-05
04719864683750Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480702480702026-02-05
04719864683996Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413602413602026-02-05
04719864684009Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413702413702026-02-05
04719864684078Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420502420502026-02-05
04719864684085Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420602420602026-02-05

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