FDA.report

Dynafit System

Primary DI
33701173702194
Brand
Dynafit System
Company
NEOSTEO
Model
S16TL26
Catalog number
S16TL26
Device description
Self compressive screw
Published
2018-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
33701173702194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3370117370219433701173702194

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

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

Regulatory Flags

DUNS number
261106831
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
03701173701905FlexitSystemS02TL70S02TL702022-05-02
03701173701929FlexitSystemS02TL75S02TL752022-05-02
03701173701943FlexitSystemS02TL80S02TL802022-05-02
03701173703657DynafitSystemA5080808A50808082020-12-15
03701173703664DynafitSystemA5101010A51010102020-12-15
03701173703671DynafitSystemA5101315A51013152020-12-15

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