Milagro
MILAGRO ADVANCE INTERFERENCE SCREW Absorbable - TCP/PLGA 11 x 35mm
2manufacturers in China registered for this device type
15catalogue numbers in this listing
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K120589 |
| Record published | 2015-09-01 |
| Record revised | 2026-04-23 (version 10) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 25 °C; Storage environment temperature up to 25 °C; Storage environment temperature up to 77 °F; Handling environment temperature up to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 231818 | In distribution | |
| 231811 | In distribution | |
| 231813 | In distribution | |
| 231812 | In distribution | |
| 231821 | In distribution | |
| 231817 | In distribution | |
| 231828 | In distribution | |
| 231814 | In distribution | |
| 231803 | In distribution | |
| 231804 | In distribution | |
| 231816 | In distribution | |
| 231822 | In distribution | |
| 231826 | In distribution | |
| 231819 | In distribution | |
| 231829 | 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
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 805 units |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 540 units |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 2372 units |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 3328 units |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 1125 units |
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.