FDA.reportPublic FDA data

DynafitSystem

Primary DI
03701173705620
Brand
DynafitSystem
Company
NEOSTEO
Model
I020210
Catalog number
I020210
Device description
Interphalangeal Joint Fusion Device, Size L, 10°, 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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701173705620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701173705620037011737056203701173705620

GMDN Terms#

Term, Definition table
TermDefinition
Interphalangeal joint arthrodesis implantA sterile implantable device designed to be inserted across a toe or finger interphalangeal joint, into the contiguous phalanges, to fuse the joint (arthrodesis), typically to correct joints damaged by traumatic, degenerative or rheumatoid arthritis, or other deformities (e.g., hammer toe), or for arthroplasty revision. It is made of metal [(e.g., stainless steel, nickel-titanium alloy (Nitinol)]) and can be of several geometric shapes (e.g., a small rod with barbs at each end, or X-shaped); 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100004HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
20810152101418DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101425DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101432DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101449DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101456DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101463DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101470DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101487DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101494DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101500DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101517DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101524DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101531DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101548DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101555DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101562DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101579DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101586DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101593DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101609DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101616DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101623DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101630DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101647DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101654DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101661DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13