Identity
- Trade Name
- OSSIOfiber® Suture Anchor FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- OSSIOfiber® Suture Anchor 2.5 mm, with 1.4 mm White/Blue Suture Tape with Needles. Package contains: 1 Implant, 1 Inserter, 1 White/Blue 1.4 mm Suture Tape, 2 Stainless Steel MO-6 Needles. FDA UDI
- Model / Reference
- OF1032553S FDA UDI
- Description
- OSSIOfiber® Suture Anchor 2.5 mm, with 1.4 mm White/Blue Suture Tape with Needles. Package contains: 1 Implant, 1 Inserter, 1 White/Blue 1.4 mm Suture Tape, 2 Stainless Steel MO-6 Needles. FDA UDI
Identifiers
- Catalog Number
- OF1032553S FDA UDI
- Primary DI / UDI-DI
- 07290019361169 FDA UDI
- 510(k) Number
- K243760 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 — 2.5 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.
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HEALIX PEEK ORTHOCORD — Medos International Sàrl · Class II
- Arthrex® — Arthrex, Inc. · Class II
- 5 x 15mm CitreLock Implant — ACUITIVE TECHNOLOGIES · Class II
- Fix2Lock — OSTEONIC CO., Ltd. · Class II
- Fixone Hybrid Anchor — AJU PHARM. CO., LTD. · Class II
- RIGIDFIX BIOCRYL — Medos International Sàrl · Class II
Cleared under the same submission
K243760 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ossio Ltd
Sources (1)
- FDA UDI 2935242d-ec31-400d-af79-526b290986ae 38 fields · synced Jun 8, 2026