FDA.reportPublic FDA data

OSSIOfiber® Trimmable Fixation Nail System, Cannulated

Primary DI
07290019361022
Brand
OSSIOfiber® Trimmable Fixation Nail System, Cannulated
Company
OSSIO LTD
Model
OF2054100S
Catalog number
OF2054100S
Device description
OSSIOfiber® Trimmable Fixation Nail System, 4.0x100mm, Cannulated. Package contains: 1 Implant, and 1 instrument pack.
Published
2024-06-30
Public version status
New
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
07290019361022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019361022072900193610227290019361022

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, bioabsorbableA device in the form of a small diameter rod intended to be 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
Length100Millimeter
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
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
07290017630571OSSIOfiber® Trimmable Fixation Nail System, CannulatedOF2054070S1OF2054070S2026-02-19
07290017630588OSSIOfiber® Threaded Trimmable Fixation NailOF1104570SOF1104570S2025-12-17
07290017630595OSSIOfiber® Threaded Trimmable Fixation Nail SystemOF2104530SOF2104530S2025-12-17
07290017630823OSSIOfiber® Compression ScrewOF1073534SOF1073534S2025-09-26
07290017630830OSSIOfiber® Compression ScrewOF1073536SOF1073536S2025-09-26
07290017630847OSSIOfiber® Compression ScrewOF1073538SOF1073538S2025-09-26
07290017630854OSSIOfiber® Compression ScrewOF1073540SOF1073540S2025-09-26
07290019361176OSSIOfiber® Suture AnchorOF1032554SOF1032554S2025-09-08
07290019361121OSSIO® Drill PackTHN00482THN004822024-10-07
07290019361138OSSIO® Drill PackTHN00483THN004832024-10-07
07290019361145OSSIO® Drill PackTHN00484THN004842024-10-07
07290019361152OSSIOfiber® Suture AnchorOF1032552SOF1032552S2025-05-29
07290019361169OSSIOfiber® Suture AnchorOF1032553SOF1032553S2025-05-29

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