OSSIOfiber® Hammertoe Fixation Implant OF10032211
GUDID 07290017630069
The OSSIOfiber® Hammertoe Fixation Implant, L, 3.2X21 mm, angled 10°. Package contains: 1 Inserter, 1 Implant angled 10°.
OSSIO LTD
Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable| Primary Device ID | 07290017630069 |
| NIH Device Record Key | 8e15a0b9-f404-4b87-9324-10110b3efafd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIOfiber® Hammertoe Fixation Implant |
| Version Model Number | OF10032211 |
| Catalog Number | OF10032211 |
| Company DUNS | 600505107 |
| Company Name | OSSIO LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io |
Device Dimensions
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Length | 21 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017630069 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190652
FDA Product Code
| HTY | Pin, Fixation, Smooth |
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 | 2020-03-20 |
| Device Publish Date | 2020-03-12 |
On-Brand Devices [OSSIOfiber® Hammertoe Fixation Implant ]
| 07290017630069 | The OSSIOfiber® Hammertoe Fixation Implant, L, 3.2X21 mm, angled 10°. Package contains: 1 Inse |
| 07290017630052 | The OSSIOfiber® Hammertoe Fixation Implant, L, 3.2X21 mm, straight 0°. Package contains: 1 Ins |
| 07290017630045 | The OSSIOfiber® Hammertoe Fixation Implant, M, 2.9X19 mm, angled 10°. Package contains: 1 Ins |
| 07290017630038 | OSSIOfiber® Hammertoe Fixation Implant, M, 2.9X19 mm, straight 0°. Package contains: 1 Inser |
| 07290017630021 | The OSSIOfiber® Hammertoe Fixation Implant, S, 2.5X16 mm angled 10°. Package contains: 1 Ins |
| 07290017630014 | The OSSIOfiber® Hammertoe Fixation Implant, S, 2.5X16 mm straight 0°. Package contains: 1 Ins |
Trademark Results [OSSIOfiber]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.