FDA.reportPublic FDA data

DynafitSystem

Primary DI
03701173703756
Brand
DynafitSystem
Company
NEOSTEO
Model
A5151515
Catalog number
A5151515
Device description
Superelastic staple 15 x 15 x 15mm sterile
Published
2020-12-15
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
JDRStaple, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192447000Superelastic StapleNeosteo2020-02-28JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701173703756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701173703756037011737037563701173703756

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

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
00815432028108DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2022-10-24
00815432026241HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
00815432026258HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
B56217634WB0Memory StapleWishbone Medical, Inc.JDR2020-08-06
00815432027255DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-06-03
00815432026111DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026128DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026135HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026142HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026180HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026197HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026203HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026326DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026340HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028788MotoBAND™ CP DynaForce®CROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028726MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028795MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028801MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028818MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028184DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432028221DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432027279DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432027286DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028115DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028122DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028139DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028146DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028153DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028160DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028177DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20