Saw
Recip SAW Blade Double-Sided Lgth 68MM/CUT THK 1.10MM-STER
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HSO |
| Device type | Saw |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2022-07-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 511.907S | In distribution | |
| 511.912S | In distribution | |
| 532.067S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Design | Surgical Design, Inc. | 23 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| Inbone™ | Wright Medical Technology, Inc. | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 5 |
| DynaBridge | Fusion Orthopedics, LLC | 5 |
| Saw | Wright Medical Technology, Inc. | 5 |
| LapiLock | Fusion Orthopedics, LLC | 4 |
| Charnley | Depuy Intl., Ltd. | 2 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 2 |
| SAW Blade | Sontec Instruments, Inc. | 1 |
| Micro-Mill® | Zimmer, Inc. | 1 |
| Saw | Zimmer, Inc. | 1 |
Showing 12 of 16. All products under Saw
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.