FDA.reportPublic FDA data

OSSIOfiber® Trimmable Fixation Nail System

Primary DI
07290017630304
Brand
OSSIOfiber® Trimmable Fixation Nail System
Company
OSSIO LTD
Model
OF2014050S
Catalog number
OF2014050S
Device description
OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 1 Implant, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.
Published
2020-09-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017630304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017630304072900176303047290017630304

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, bioabsorbableA device in the form of a small diameter rod used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Outer Diameter4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store at a normal relative humidity
Storage Environment Temperature7 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-781-7373customer_service@ossio.io

Regulatory Flags#

DUNS number
600505107
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019361435OSSIOfiber® Interference ScrewOF1168028SOF1168028S2026-10-21
07290019361442OSSIOfiber® Interference ScrewOF1169028SOF1169028S2026-10-21
07290019361459OSSIOfiber® Interference ScrewOF1161028SOF1161028S2026-10-21
07290019361466OSSIOfiber® Interference ScrewOF1161128SOF1161128S2026-10-21
07290019361206OSSIOfiber® Interference ScrewOF1168023SOF1168023S2026-07-19
07290019361213OSSIOfiber® Interference ScrewOF1169023SOF1169023S2026-07-19
07290019361220OSSIOfiber® Interference ScrewOF1161023SOF1161023S2026-07-19
07290019361336OSSIO® InserterTHN00633THN006332026-07-19
07290019361343OSSIO® TapTHN00634THN006342026-07-19
07290019361350OSSIO® TapTHN00636THN006362026-07-19
07290019361367OSSIO® TapTHN00638THN006382026-07-19
07290019361374OSSIO® TapTHN00640THN006402026-07-19
07290019361381OSSIO® TapTHN00642THN006422026-07-19
07290019361190OSSIOfiber® Interference ScrewOF1167023SOF1167023S2026-05-13
07290017630946OSSIOfiber® Suture AnchorOF1035551SOF1035551S2023-09-14
07290017630601OSSIOfiber® Suture AnchorOF1034751SOF1034751S2022-06-06
07290017630618OSSIOfiber® Suture AnchorOF1034752SOF1034752S2022-06-06
07290017630625OSSIOfiber® Suture AnchorOF1034753SOF1034753S2022-06-06
07290017630632OSSIOfiber® Suture AnchorOF1034754SOF1034754S2022-06-06
07290017630649OSSIOfiber® Suture AnchorOF1034755SOF1034755S2022-06-06

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