FDA.reportPublic FDA data

OSSIOfiber® Compression Screw

Primary DI
07290017630397
Brand
OSSIOfiber® Compression Screw
Company
OSSIO LTD
Model
OF1024056S
Catalog number
OF1024056S
Device description
OSSIOfiber® Compression Screw, 4.0X56 mm. Package contains: 1 Implant.
Published
2021-06-20
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193660000
K231272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193660000OSSIOfiber™ Compression ScrewsOSSIO , Ltd.2020-07-30HWC
K231272000OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailOSSIO , Ltd.2023-12-01HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017630397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017630397072900176303977290017630397

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA small, sterile, threaded 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). This device may be used in maxillofacial surgery. There are a number of 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
Length56Millimeter
Outer Diameter4Millimeter

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
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
07290017630571OSSIOfiber® Trimmable Fixation Nail System, CannulatedOF2054070S1OF2054070S2026-02-19
07290017630588OSSIOfiber® Threaded Trimmable Fixation NailOF1104570SOF1104570S2025-12-17
07290017630595OSSIOfiber® Threaded Trimmable Fixation Nail SystemOF2104530SOF2104530S2025-12-17
07290017630823OSSIOfiber® Compression ScrewOF1073534SOF1073534S2025-09-26
07290017630830OSSIOfiber® Compression ScrewOF1073536SOF1073536S2025-09-26
07290017630847OSSIOfiber® Compression ScrewOF1073538SOF1073538S2025-09-26
07290017630854OSSIOfiber® Compression ScrewOF1073540SOF1073540S2025-09-26
07290019361176OSSIOfiber® Suture AnchorOF1032554SOF1032554S2025-09-08
07290019361121OSSIO® Drill PackTHN00482THN004822024-10-07
07290019361138OSSIO® Drill PackTHN00483THN004832024-10-07
07290019361145OSSIO® Drill PackTHN00484THN004842024-10-07
07290019361152OSSIOfiber® Suture AnchorOF1032552SOF1032552S2025-05-29
07290019361169OSSIOfiber® Suture AnchorOF1032553SOF1032553S2025-05-29

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