OSSIOfiber® Interference Screw
OSSIOfiber® Interference Screw, 10.0x23 mm. Package contains: 1 Implant.
2manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Ossio Ltd., Israel |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2026-07-19 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 7 to 30 °C; Special storage condition: Keep dry; Special storage condition: Store at a normal relative humidity; Special storage condition: Do not expose product to temperatures greater than 47°C or 116°F |
| Sizes | Outer diameter 7 to 10 mm; length 23 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OF1161023S | Outer Diameter 10.0 mm | In distribution |
| OF1167023S | Outer Diameter 7.0 mm | In distribution |
| OF1169023S | Outer Diameter 9.0 mm | In distribution |
| OF1168023S | Outer Diameter 8.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254055 | 2026-02-24 |
| K252022 | 2025-08-19 |
| K251309 | 2025-05-27 |
| K243760 | 2025-04-03 |
| K213415 | 2022-03-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.