Delta
Delta 1.7MM 3X21 Hybrid Cntrsinks 0.75MM
2manufacturers in China registered for this device type
110catalogue 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 | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K213777 |
| Record published | 2015-09-24 |
| Record revised | 2024-06-19 (version 10) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 49 °C |
| Packaging | Pack of 2 |
| Sizes | Length 3 to 150 mm; width 11 to 122 mm; angle 110 °; length 7 cm |
| Distribution end date | 2019-07-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70-92057 | 3D Plates: 1×21 Holes | In distribution | |
| 70-06330 | 3D Plates: 2×5 Holes | In distribution | |
| 70-92001 | Length 144.0 mm | In distribution | |
| 73-17206 | Diameter: 1.7 Millimeter | 2 | In distribution |
| 70-05356 | Number of Screw Holes: 49.0 Holes | In distribution | |
| 70-05345 | Thickness: 0.75 Millimeter | In distribution | |
| 70-26208 | Diameter: 2.6 Millimeter | 2 | In distribution |
| 70-05166 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 70-17104 | Length 4.0 mm | 10 | In distribution |
| 73-17104 | Length 4.0 mm | 10 | In distribution |
| 70-92042 | Thickness: 1.4 Millimeter | In distribution | |
| 73-22408 | Length 8.0 mm | 4 | In distribution |
| 70-26206 | Diameter: 2.6 Millimeter | 2 | In distribution |
| 70-05310 | 3D Plates: 2×2 Holes | In distribution | |
| 75-17123 | Diameter: 1.7 Millimeter | 12 | In distribution |
| 70-05330 | 3D Plates: 2×5 Holes | In distribution | |
| 70-05114 | Number of Screw Holes: 14.0 Holes | In distribution | |
| 73-26008 | Length 8.0 mm | In distribution | |
| 75-72270 | Length 50.0 mm | In distribution | |
| 70-06355 | Thickness: 1.4 Millimeter | In distribution | |
| 73-22006 | Diameter: 2.2 Millimeter | In distribution | |
| 73-22104 | Length 4.0 mm | 10 | In distribution |
| 70-22406 | Length 6.0 mm | 4 | In distribution |
| 73-17103 | Diameter: 1.7 Millimeter | 10 | In distribution |
| 73-17203 | Length 3.0 mm | 2 | In distribution |
| 70-06141 | Angle 110.0 ° | In distribution | |
| 73-22106 | Diameter: 2.2 Millimeter | 10 | In distribution |
| 70-06188 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 75-26408 | Diameter: 2.6 Millimeter | 4 | In distribution |
| 70-06121 | Number of Screw Holes: 21.0 Holes | In distribution | |
| 73-22204 | Length 4.0 mm | 2 | In distribution |
| 70-05141 | Angle 110.0 ° | In distribution | |
| 70-05156 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 70-05350 | Width 122.0 mm | In distribution | |
| 70-05168 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 73-22210 | Length 10.0 mm | 2 | In distribution |
| 70-92019 | Width 11.0 mm | In distribution | |
| 73-22004 | Length 4.0 mm | In distribution | |
| 70-92043 | Thickness: 1.4 Millimeter | In distribution | |
| 73-17405 | Length 5.0 mm | 4 | In distribution |
| 73-22406 | Diameter: 2.2 Millimeter | 4 | In distribution |
| 73-22404 | Length 4.0 mm | 4 | In distribution |
| 70-92012 | Thickness: 0.75 Millimeter | In distribution | |
| 70-92069 | Length 4.0 mm | 2 | In distribution |
| 73-22206 | Diameter: 2.2 Millimeter | 2 | In distribution |
| 70-05365 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 70-92046 | Thickness: 0.5 Millimeter | In distribution | |
| 70-17203 | Diameter: 1.7 Millimeter | 2 | In distribution |
| 70-06108 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 70-92061 | Thickness: 0.75 Millimeter | In distribution | |
| 75-22126 | Diameter: 2.2 Millimeter | 12 | In distribution |
| 70-17205 | Diameter: 1.7 Millimeter | 2 | In distribution |
| 70-06365 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 70-17204 | Length 4.0 mm | 2 | In distribution |
| 73-17406 | Diameter: 1.7 Millimeter | 4 | In distribution |
| 70-17105 | Diameter: 1.7 Millimeter | 10 | In distribution |
| 70-06168 | Number of Screw Holes: 10.0 Holes | In distribution | |
| 70-92055 | Thickness: 0.5 Millimeter | In distribution | |
| 70-06140 | Number of Screw Holes: 9.0 Holes | In distribution | |
| 70-17404 | Length 4.0 mm | 4 | In distribution |
| 70-06114 | Number of Screw Holes: 14.0 Holes | In distribution | |
| 73-26206 | Length 6.0 mm | In distribution | |
| 75-17205 | Length 5.0 mm | 20 | In distribution |
| 75-17405 | Diameter: 1.7 Millimeter | 4 | In distribution |
| 73-17105 | Diameter: 1.7 Millimeter | 10 | In distribution |
| 73-26006 | Diameter: 2.6 Millimeter | In distribution | |
| 73-17205 | Diameter: 1.7 Millimeter | 2 | In distribution |
| 73-26208 | Diameter: 2.6 Millimeter | 2 | In distribution |
| 70-17206 | Length 6.0 mm | 2 | In distribution |
| 70-26210 | Length 10.0 mm | 2 | In distribution |
| 70-06104 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 70-17405 | Length 5.0 mm | 4 | In distribution |
| 70-22404 | Diameter: 2.2 Millimeter | 4 | In distribution |
| 70-26010 | Length 10.0 mm | In distribution | |
| 73-17204 | Diameter: 1.7 Millimeter | 2 | In distribution |
| 70-17403 | Length 3.0 mm | 4 | In distribution |
| 70-22208 | Length 8.0 mm | 2 | In distribution |
| 70-26006 | Diameter: 2.6 Millimeter | In distribution | |
| 70-06356 | Number of Screw Holes: 49.0 Holes | In distribution | |
| 70-06158 | Number of Screw Holes: 9.0 Holes | In distribution | |
| 70-06345 | Thickness: 1.0 Millimeter | In distribution | |
| 70-05355 | Thickness: 1.0 Millimeter | In distribution | |
| 70-26008 | Diameter: 2.6 Millimeter | In distribution | |
| 70-05140 | Angle 110.0 ° | In distribution | |
| 75-17420 | Length 4.0 mm | 20 | In distribution |
| 70-22204 | Diameter: 2.2 Millimeter | 2 | In distribution |
| 70-92045 | 3D Plates: 3×21 Holes | In distribution | |
| 70-22408 | Diameter: 2.2 Millimeter | 4 | In distribution |
| 70-92060 | Thickness: 0.75 Millimeter | In distribution | |
| 70-92056 | 3D Plates: 1×21 Holes | In distribution | |
| 73-22208 | Length 8.0 mm | 2 | In distribution |
| 70-17406 | Length 6.0 mm | 4 | In distribution |
| 75-22124 | Length 4.0 mm | 12 | In distribution |
| 70-17103 | Diameter: 1.7 Millimeter | 10 | In distribution |
| 73-17404 | Diameter: 1.7 Millimeter | 4 | In distribution |
| 73-17403 | Length 3.0 mm | 4 | In distribution |
| 70-22104 | Diameter: 2.2 Millimeter | 10 | In distribution |
| 70-22210 | Diameter: 2.2 Millimeter | 2 | In distribution |
| 70-92020 | Width 17.0 mm | In distribution | |
| 70-22206 | Diameter: 2.2 Millimeter | 2 | In distribution |
| 73-26010 | Diameter: 2.6 Millimeter | In distribution | |
| 70-22106 | Diameter: 2.2 Millimeter | 10 | In distribution |
| 75-17203 | Diameter: 1.7 Millimeter | 20 | In distribution |
| 73-26210 | Diameter: 2.6 Millimeter | 2 | In distribution |
| 70-05348 | Number of Screw Holes: 11.0 Holes | In distribution | |
| 70-22006 | Diameter: 2.2 Millimeter | In distribution | |
| 70-22004 | Length 4.0 mm | In distribution | |
| 73-71780 | Length 7.0 cm | Withdrawn | |
| 73-72680 | Diameter: 2.6 Millimeter | Withdrawn | |
| 73-72280 | Length 15.6 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| 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 |
| Twist AP Suture Anchors | Parcus Medical, LLC | 17 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
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.