FDA.reportPublic FDA data

OSSIOfiber® Threaded Trimmable Fixation Nail

Primary DI
07290019361107
Brand
OSSIOfiber® Threaded Trimmable Fixation Nail
Company
OSSIO LTD
Model
OF1095570S
Catalog number
OF1095570S
Device description
OSSIOfiber® Threaded Trimmable Fixation Nail, 5.5x70mm. Package contains: 1 Implant.
Published
2024-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241277000OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd.2024-07-03HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019361107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019361107072900193611077290019361107

GMDN Terms#

Term, Definition table
TermDefinition
Bioabsorbable orthopaedic bone screwA small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter
Outer Diameter5.5Millimeter

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
1-833-781-7373customer_service@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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