FDA.reportPublic FDA data

DynafitSystem

Primary DI
03701173705606
Brand
DynafitSystem
Company
NEOSTEO
Model
I020010
Catalog number
I020010
Device description
Interphalangeal Joint Fusion Device, Size S, 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
03701173705606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701173705606037011737056063701173705606

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
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
03701173701905FlexitSystemS02TL70S02TL702022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCHWC2026-07-17
07613327646825NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646832NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646849NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646856NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646863NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646870NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646887NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646894NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646900NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646917NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646931NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646948NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646955NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646962NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646979NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646986NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646993NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647006NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647013NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647020NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647037NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647044NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647051NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647069NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647076NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647090NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647106NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647113NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647120NAStryker Leibinger GmbH & Co. KGHWC2026-07-17