Blade, Saw, General & Plastic Surgery, Surgical
Micro Precision Saw Blade Thin Oscillating & Sagittal
Who Else Makes It
Concentrated in Zhejiang (7), Guangdong (7), Shanghai (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Dongguan Miqiang Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Zhejiang Longyou Landmedical Technology Co., Ltd. | Longyou | Zhejiang | Contract manufacturer | 7 |
| Ningbo Advan Electrical Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
Showing 12 of 25. All 25 manufacturers in China registered for Blade, Saw, General & Plastic Surgery, Surgical
Record
| Listed by | Stryker Sustainability Solutions, United States |
|---|---|
| FDA product code | GFA |
| Device type | Blade, Saw, General & Plastic Surgery, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-12-19 (version 6) |
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 |
| Sizes | Width 5.5 to 40.5 mm; depth 18 to 105 mm |
| Distribution end date | 2024-12-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | Width 10.0 mm | Withdrawn |
| N/A | Depth 73.0 mm | Withdrawn |
| N/A | Depth 25.0 mm | Withdrawn |
| N/A | Depth 100.0 mm | Withdrawn |
| N/A | Depth 41.0 mm | Withdrawn |
| N/A | Width 18.5 mm | Withdrawn |
| N/A | Depth 73.0 mm | Withdrawn |
| N/A | Depth 90.0 mm | Withdrawn |
| N/A | Depth 79.5 mm | Withdrawn |
| N/A | Width 11.0 mm | Withdrawn |
| N/A | Width 6.27 mm | Withdrawn |
| N/A | Width 35.0 mm | Withdrawn |
| N/A | Width 36.0 mm | Withdrawn |
| N/A | Depth 86.0 mm | Withdrawn |
| N/A | Depth 32.0 mm | Withdrawn |
| N/A | Depth 88.0 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Width 25.4 mm | Withdrawn |
| N/A | Material Thickness: 0.64 Millimeter | Withdrawn |
| N/A | Depth 25.5 mm | Withdrawn |
| N/A | Depth 73.0 mm | Withdrawn |
| N/A | Width 12.5 mm | Withdrawn |
| N/A | Depth 85.0 mm | Withdrawn |
| N/A | Width 25.4 mm | Withdrawn |
| N/A | Depth 24.0 mm | Withdrawn |
| N/A | Depth 81.5 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Material Thickness: 1.25 Millimeter | Withdrawn |
| N/A | Width 13.0 mm | Withdrawn |
| N/A | Width 9.5 mm | Withdrawn |
| N/A | Depth 100.0 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Depth 105.0 mm | Withdrawn |
| N/A | Material Thickness: 1.19 Millimeter | Withdrawn |
| N/A | Material Thickness: 0.38 Millimeter | Withdrawn |
| N/A | Material Thickness: 1.35 Millimeter | Withdrawn |
| N/A | Width 18.5 mm | Withdrawn |
| N/A | Width 9.0 mm | Withdrawn |
| N/A | Width 12.5 mm | Withdrawn |
| N/A | Width 5.5 mm | Withdrawn |
| N/A | Width 19.5 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Width 9.5 mm | Withdrawn |
| N/A | Material Thickness: 0.89 Millimeter | Withdrawn |
| N/A | Width 19.5 mm | Withdrawn |
| N/A | Width 19.0 mm | Withdrawn |
| N/A | Depth 98.5 mm | Withdrawn |
| N/A | Depth 83.5 mm | Withdrawn |
| N/A | Depth 80.0 mm | Withdrawn |
| N/A | Material Thickness: 1.27 Millimeter | Withdrawn |
| N/A | Width 33.5 mm | Withdrawn |
| N/A | Width 19.5 mm | Withdrawn |
| N/A | Material Thickness: 1.27 Millimeter | Withdrawn |
| N/A | Diameter: 0.75 Inch | Withdrawn |
| N/A | Depth 29.5 mm | Withdrawn |
| N/A | Depth 85.0 mm | Withdrawn |
| N/A | Material Thickness: 1.27 Millimeter | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Material Thickness: 0.64 Millimeter | Withdrawn |
| N/A | Width 19.0 mm | Withdrawn |
| N/A | Width 19.0 mm | Withdrawn |
| N/A | Width 18.0 mm | Withdrawn |
| N/A | Material Thickness: 0.89 Millimeter | Withdrawn |
| N/A | Material Thickness: 1.27 Millimeter | Withdrawn |
| N/A | Width 18.0 mm | Withdrawn |
| N/A | Material Thickness: 1.27 Millimeter | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Depth 90.0 mm | Withdrawn |
| N/A | Depth 73.0 mm | Withdrawn |
| N/A | Material Thickness: 0.32 Millimeter | Withdrawn |
| N/A | Width 18.5 mm | Withdrawn |
| N/A | Material Thickness: 0.89 Millimeter | Withdrawn |
| N/A | Depth 63.0 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Depth 18.5 mm | Withdrawn |
| N/A | Depth 18.5 mm | Withdrawn |
| N/A | Material Thickness: 1.27 Millimeter | Withdrawn |
| N/A | Depth 60.5 mm | Withdrawn |
| N/A | Width 29.0 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Depth 64.0 mm | Withdrawn |
| N/A | Width 19.5 mm | Withdrawn |
| N/A | Material Thickness: 1.15 Millimeter | Withdrawn |
| N/A | Width 18.5 mm | Withdrawn |
| N/A | Width 18.0 mm | Withdrawn |
| N/A | Width 18.5 mm | Withdrawn |
| N/A | Depth 85.0 mm | Withdrawn |
| N/A | Material Thickness: 0.8 Millimeter | Withdrawn |
| N/A | Depth 90.0 mm | Withdrawn |
| N/A | Depth 90.0 mm | Withdrawn |
| N/A | Material Thickness: 1.3 Millimeter | Withdrawn |
| N/A | Width 25.35 mm | Withdrawn |
| N/A | Width 19.5 mm | Withdrawn |
| N/A | Material Thickness: 0.38 Millimeter | Withdrawn |
| N/A | Width 6.8 mm | Withdrawn |
| N/A | Depth 25.5 mm | Withdrawn |
| N/A | Depth 64.0 mm | Withdrawn |
| N/A | Material Thickness: 1.2 Millimeter | Withdrawn |
| N/A | Material Thickness: 1.19 Millimeter | Withdrawn |
| N/A | Material Thickness: 0.89 Millimeter | Withdrawn |
| N/A | Depth 79.5 mm | Withdrawn |
| N/A | Material Thickness: 0.6 Millimeter | Withdrawn |
| N/A | Depth 60.0 mm | Withdrawn |
| N/A | Material Thickness: 0.8 Millimeter | Withdrawn |
| N/A | Material Thickness: 1.35 Millimeter | Withdrawn |
| N/A | Depth 31.0 mm | Withdrawn |
| N/A | Depth 79.5 mm | Withdrawn |
| N/A | Material Thickness: 1.27 Millimeter | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
| N/A | Width 12.5 mm | Withdrawn |
| N/A | Depth 47.5 mm | Withdrawn |
| N/A | Depth 75.0 mm | Withdrawn |
| N/A | Width 25.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imedicom SAW Blade | Imedicom Co., Ltd. | 1,283 |
| Stablecut® | Zimmer Orthopaedic Surgical Products | 1,154 |
| Medline | Medline Industries, Inc. | 999 |
| Blade, Saw, General & Plastic Surgery, Surgical | Sterilmed, Inc. | 994 |
| Komet Surgical Saw Blade | Gebr. Brasseler Gmbh & Co. KG | 843 |
| Stryker | Provision | 613 |
| Blade, Saw, General & Plastic Surgery, Surgical | Omega Surgical Instruments, Inc. | 490 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 438 |
| Blade, Saw, General & Plastic Surgery, Surgical | Stryker GmbH | 430 |
| Arthrex® | Arthrex, Inc. | 213 |
| MicroAire | Provision | 175 |
| Conmed/Linvatec | Provision | 175 |
Showing 12 of 488. All products under Blade, Saw, General & Plastic Surgery, Surgical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-10-14 | Class II | Employee error | It was reported that packaging was not properly sealed. | 1202 | 2016-05-06 |
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.