FDA.reportPublic FDA data

Dynafit System

Primary DI
33701173702521
Brand
Dynafit System
Company
NEOSTEO
Model
S18TL28
Catalog number
S18TL28
Device description
Self compressive screw
Published
2018-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33701173702521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3370117370252133701173702521

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Device must be stored in a place protected from light and humidity.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
261106831
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701173705576DynafitSystemI020000I0200002020-12-15
03701173705583DynafitSystemI020100I0201002020-12-15
03701173705590DynafitSystemI020200I0202002020-12-15
03701173705606DynafitSystemI020010I0200102020-12-15
03701173705613DynafitSystemI020110I0201102020-12-15
03701173705620DynafitSystemI020210I0202102020-12-15
03701173701431FlexitSystemPTR002-6PTR002-62022-05-02
03701173701448FlexitSystemPTL002-6PTL002-62022-05-02
03701173701462FlexitSystemPTS001-6PTS001-62022-05-02
03701173701479FlexitSystemPTS001-7PTS001-72022-05-02
03701173701486FlexitSystemPTS003-10PTS003-102022-05-02
03701173701721FlexitSystemS02TL25S02TL252022-05-02
03701173701745FlexitSystemS02TL30S02TL302022-05-02
03701173701769FlexitSystemS02TL35S02TL352022-05-02
03701173701783FlexitSystemS02TL40S02TL402022-05-02
03701173701806FlexitSystemS02TL45S02TL452022-05-02
03701173701820FlexitSystemS02TL50S02TL502022-05-02
03701173701844FlexitSystemS02TL55S02TL552022-05-02
03701173701868FlexitSystemS02TL60S02TL602022-05-02
03701173701882FlexitSystemS02TL65S02TL652022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809958988710Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958988727Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958988734Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989175Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989182Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989199Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989205Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989212Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989229Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989236Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989243Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989250Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989267Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989274Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989281Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989298Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989304Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989311Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989328Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989335Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989342Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989359Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989366Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989373Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989380Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989397Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989403Montblanc Cortical ScrewMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989694Montblanc Locking Screw - B typeMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989700Montblanc Locking Screw - B typeMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22
08809958989717Montblanc Locking Screw - B typeMEDIFIELD MEDICAL Co., Ltd.HWC2026-06-22