OSSIOfiber® Hammertoe Fixation System OF20025161

GUDID 07290017630083

The OSSIOfiber® Hammertoe Fixation System, S, 2.5X16 mm, angled 10°. Package contains: 1 K-wire, 1 Drill-Bit, 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 ID07290017630083
NIH Device Record Keyaa13b917-eb97-4fbf-805d-715610314c65
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSIOfiber® Hammertoe Fixation System
Version Model NumberOF20025161
Catalog NumberOF20025161
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

Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 Millimeter
Outer Diameter2.5 Millimeter
Length16 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
GS107290017630083 [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 System]

07290017630120The OSSIOfiber® Hammertoe Fixation System, L, 3.2X21 mm, angled 10°. Package contains: 1 K-wir
07290017630113The OSSIOfiber® Hammertoe Fixation System, L, 3.2X21 mm, straight 0°. Package contains: 1 K-wi
07290017630106The OSSIOfiber® Hammertoe Fixation System, M, 2.9X19 mm, angled 10°. Package contains: 1 K-wi
07290017630090The OSSIOfiber® Hammertoe Fixation System, M, 2.9X19 mm, straight 0°. Package contains: 1 K-w
07290017630083The OSSIOfiber® Hammertoe Fixation System, S, 2.5X16 mm, angled 10°. Package contains: 1 K-wir
07290017630076The OSSIOfiber® Hammertoe Fixation System, S, 2.5X16 mm, straight 0°. Package contains: 1 K-w

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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