FDA.reportPublic FDA data

OSSIOfiber® Suture Anchor

Primary DI
07290017630601
Brand
OSSIOfiber® Suture Anchor
Company
OSSIO LTD
Model
OF1034751S
Catalog number
OF1034751S
Device description
OSSIOfiber® Suture Anchor 4.75 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 Suture Snare.
Published
2022-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213415000
K251309000
K254055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213415000OSSIOfiber Suture AnchorOSSIO , Ltd.2022-03-28MAI
K251309000OSSIOfiber® Suture AnchorOSSIO , Ltd.2025-05-27MAI
K254055000OSSIOfiber® Suture AnchorOSSIO , Ltd.2026-02-24MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017630601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017630601072900176306017290017630601

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.75Millimeter

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867627840Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MAI2026-10-07
20845854655501Argo KnotlessConmed CorporationMAI2026-09-25
20653405990908GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990915GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990922GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990939GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990946GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990953GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
07290019361206OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361213OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361220OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
00888867304598Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304604Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304789Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304796Arthrex®ARTHREX, INC.MAI2026-07-08
00816537023012FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00888867483927Arthrex®ARTHREX, INC.MAI2025-11-06
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHMAI2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHMAI2025-10-01