OSSIOfiber® Hammertoe Fixation Implant OF10029190

GUDID 07290017630038

OSSIOfiber® Hammertoe Fixation Implant, M, 2.9X19 mm, straight 0°. Package contains: 1 Inserter, 1 Implant straight 0°.

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 ID07290017630038
NIH Device Record Key13afe0bb-f09e-460b-b50b-2492f3937d90
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSIOfiber® Hammertoe Fixation Implant
Version Model NumberOF10029190
Catalog NumberOF10029190
Company DUNS600505107
Company NameOSSIO LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io

Device Dimensions

Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter
Outer Diameter2.9 Millimeter
Length19 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a normal relative humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 7 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017630038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-20
Device Publish Date2020-03-12

On-Brand Devices [OSSIOfiber® Hammertoe Fixation Implant ]

07290017630069The OSSIOfiber® Hammertoe Fixation Implant, L, 3.2X21 mm, angled 10°. Package contains: 1 Inse
07290017630052The OSSIOfiber® Hammertoe Fixation Implant, L, 3.2X21 mm, straight 0°. Package contains: 1 Ins
07290017630045The OSSIOfiber® Hammertoe Fixation Implant, M, 2.9X19 mm, angled 10°. Package contains: 1 Ins
07290017630038OSSIOfiber® Hammertoe Fixation Implant, M, 2.9X19 mm, straight 0°. Package contains: 1 Inser
07290017630021The OSSIOfiber® Hammertoe Fixation Implant, S, 2.5X16 mm angled 10°. Package contains: 1 Ins
07290017630014The 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
OSSIOFIBER
79255262 not registered Live/Pending
OSSIO LTD
2018-11-29

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