FDA.reportPublic FDA data

OSSIOfiber™ Hammertoe Fixation Implant

Primary DI
07290017630007
Brand
OSSIOfiber™ Hammertoe Fixation Implant
Company
OSSIO LTD
Model
2.9X19 mm straight
Catalog number
OF10129190
Device description
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).
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181180000OSSIO™ Pin Product FamilyOSSIO , Ltd.2019-01-10HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017630007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017630007072900176300077290017630007

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, bioabsorbableA device in the form of a small diameter rod used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Millimeter
Outer Diameter2.9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store at a normal relative humidity
Storage Environment Temperature7 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-781-7373info@ossio.io

Regulatory Flags#

DUNS number
600505107
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019361435OSSIOfiber® Interference ScrewOF1168028SOF1168028S2026-10-21
07290019361442OSSIOfiber® Interference ScrewOF1169028SOF1169028S2026-10-21
07290019361459OSSIOfiber® Interference ScrewOF1161028SOF1161028S2026-10-21
07290019361466OSSIOfiber® Interference ScrewOF1161128SOF1161128S2026-10-21
07290019361206OSSIOfiber® Interference ScrewOF1168023SOF1168023S2026-07-19
07290019361213OSSIOfiber® Interference ScrewOF1169023SOF1169023S2026-07-19
07290019361220OSSIOfiber® Interference ScrewOF1161023SOF1161023S2026-07-19
07290019361336OSSIO® InserterTHN00633THN006332026-07-19
07290019361343OSSIO® TapTHN00634THN006342026-07-19
07290019361350OSSIO® TapTHN00636THN006362026-07-19
07290019361367OSSIO® TapTHN00638THN006382026-07-19
07290019361374OSSIO® TapTHN00640THN006402026-07-19
07290019361381OSSIO® TapTHN00642THN006422026-07-19
07290019361190OSSIOfiber® Interference ScrewOF1167023SOF1167023S2026-05-13
07290017630946OSSIOfiber® Suture AnchorOF1035551SOF1035551S2023-09-14
07290017630601OSSIOfiber® Suture AnchorOF1034751SOF1034751S2022-06-06
07290017630618OSSIOfiber® Suture AnchorOF1034752SOF1034752S2022-06-06
07290017630625OSSIOfiber® Suture AnchorOF1034753SOF1034753S2022-06-06
07290017630632OSSIOfiber® Suture AnchorOF1034754SOF1034754S2022-06-06
07290017630649OSSIOfiber® Suture AnchorOF1034755SOF1034755S2022-06-06

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