Blade, Saw, Surgical, Cardiovascular
2108 Series Sagittal Blade Sternum Revision (80.0 x 0.64 x 28.5mm)
2manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | DWH |
| Device type | Blade, Saw, Surgical, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-23 |
| Record revised | 2022-01-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 100 |
| Sizes | Depth 6.2 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2108137000 | Material Thickness: 0.64 Millimeter | In distribution |
| 0298097100S3 | Material Thickness: 0.79 Millimeter | In distribution |
| 5301040032 | Cut Thickness: 0.94 Millimeter | In distribution |
| 0298097101S4 | Cut Edge: 31.7 Millimeter | In distribution |
| 0298097100 | Depth 6.3 mm | In distribution |
| 0296097102 | Material Thickness: 0.64 Millimeter | In distribution |
| 5301040033 | Material Thickness: 0.64 Millimeter | In distribution |
| 0298097100S1 | Cut Thickness: 1.02 Millimeter | In distribution |
| 0298097101S5 | Cut Edge: 45.9 Millimeter | In distribution |
| 0298097101 | Cut Edge: 31.7 Millimeter | In distribution |
| 0298097104 | Depth 6.3 mm | In distribution |
| 5100134280 | Cut Edge: 53.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Symmetry Ultra™ Reveal | Aspen Surgical Products, Inc. | 11 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 7 |
| Traus | Saeshin Precision Co., Ltd. | 5 |
| Millennium | Avalign Technologies, Inc. | 4 |
| Aesculap | Aesculap AG | 3 |
| Stryker Performance Series | Stryker GmbH | 2 |
| Symmetry Jacobson | Aspen Surgical Products, Inc. | 1 |
| Symmetry Scoville | Aspen Surgical Products, Inc. | 1 |
| Symmetry Taylor | Aspen Surgical Products, Inc. | 1 |
| Symmetry Scoville-Meyerding | Aspen Surgical Products, Inc. | 1 |
| Symmetry Wolff-Boehler | Aspen Surgical Products, Inc. | 1 |
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.