OSSIOfiber® Trimmable Fixation Nail System OF2012450S
GUDID 07290017630274
OSSIOfiber® Trimmable Fixation Nail System, 2.4x50mm. Package contains: 1 Implant, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.
OSSIO LTD
Orthopaedic surgical procedure kit, non-medicated, single-use| Primary Device ID | 07290017630274 |
| NIH Device Record Key | 2f1712c4-197b-4e9f-b37c-54ab9e986781 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIOfiber® Trimmable Fixation Nail System |
| Version Model Number | OF2012450S |
| Catalog Number | OF2012450S |
| Company DUNS | 600505107 |
| Company Name | OSSIO LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 2.4 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017630274 [Primary] |
FDA Product Code
| OJH | Orthopedic Tray |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2020-06-15 |
On-Brand Devices [OSSIOfiber® Trimmable Fixation Nail System]
| 07290017630274 | OSSIOfiber® Trimmable Fixation Nail System, 2.4x50mm. Package contains: 1 Implant, 1 Insertion |
| 07290017630267 | OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm. Package contains: 2 Implants, 1 Insertion |
| 07290017630311 | OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 2 Implants, 1 Insertio |
| 07290017630304 | OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 1 Implant, 1 Insertion |
Trademark Results [OSSIOfiber]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.