Identity
- Trade Name
- OSSIOfiber® Suture Anchor FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- OSSIOfiber® Suture Anchor 4.75 mm with Black Tape, Blue/White #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black 2mm Suture Tape, 1 Blue/White Round #2 Suture. FDA UDI
- Model / Reference
- OF1034754S FDA UDI
- Description
- OSSIOfiber® Suture Anchor 4.75 mm with Black Tape, Blue/White #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black 2mm Suture Tape, 1 Blue/White Round #2 Suture. FDA UDI
Identifiers
- Catalog Number
- OF1034754S FDA UDI
- Primary DI / UDI-DI
- 07290017630632 FDA UDI
- FDA Product Code
- MAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.75 Millimeter FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbable
OSSIOfiber® Suture Anchor by Ossio Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, bioabsorbable.
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- RIGIDFIX BIOCRYL — Medos International Sàrl · Class II
Cleared under the same submission
K213415 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ossio Ltd
Sources (1)
- FDA UDI ab10b6a9-8493-4ad0-9d3a-23add024653a 38 fields · synced May 31, 2026