OSSIOfiber™ Hammertoe Fixation Implant OF10129190
GUDID 07290017630007
The OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
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 | 07290017630007 |
| NIH Device Record Key | 78d7e0f8-765f-42dc-be01-d21b0d98c6b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIOfiber™ Hammertoe Fixation Implant |
| Version Model Number | 2.9X19 mm straight |
| Catalog Number | OF10129190 |
| 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 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io | |
| Phone | 1-833-781-7373 |
| info@ossio.io |
Device Dimensions
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
| Length | 19 Millimeter |
| Outer Diameter | 2.9 Millimeter |
Operating and Storage Conditions
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017630007 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181180
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 | 2019-04-23 |
| Device Publish Date | 2019-04-15 |
Devices Manufactured by OSSIO LTD
| 07290019361060 - OSSIOfiber® Trimmable Fixation Nail, Cannulated | 2024-02-02 OSSIOfiber® Trimmable Fixation Nail, 4.0x100mm, Cannulated. Package contains: 1 Implant. |
| 07290019361046 - OSSIO® Staple Sizing Guide | 2023-10-31 OSSIO® Staple Sizing Guide. |
| 07290017630946 - OSSIOfiber® Suture Anchor | 2023-09-22 OSSIOfiber® Suture Anchor 5.5 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 Suture Snare. |
| 07290017630953 - OSSIO® Drill Bit & Drill Guide Pack | 2023-09-22 OSSIO® Drill Bit & Drill Guide Pack, For 5.5 mm Suture Anchor. Package contains: 1 Instrument Pack. |
| 07290017630960 - OSSIO® Punch Pack | 2023-09-22 OSSIO® Punch Pack, For 5.5 mm Suture Anchor. |
| 07290017630984 - OSSIO® Tap Pack | 2023-09-22 OSSIO® Tap Pack, For 5.5 mm Suture Anchor. |
| 07290019361053 - OSSIO® Drill Bit 2.5 mm For Staple | 2023-08-03 OSSIO® Drill Bit 2.5 mm For Staple |
| 07290017630977 - OSSIO® Tap Pack | 2023-05-31 OSSIO® Tap Pack, For 4.75 mm Suture Anchor. |
Trademark Results [OSSIOfiber]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |
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