Stryker Performance Series
Stryker Performance Series Sagittal Blade
25manufacturers in China registered for this device type
43catalogue numbers in this listing
2recalls on this code
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 GmbH, Switzerland |
|---|---|
| FDA product code | GFA |
| Device type | Blade, Saw, General & Plastic Surgery, Surgical |
| 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 | 2022-04-04 (version 3) |
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 | Depth 60 to 110 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6113127060 | Cut Edge: 13.0 Millimeter | In distribution |
| 6113137090 | Depth 90.0 mm | In distribution |
| 6125137110 | Material Thickness: 1.37 Millimeter | In distribution |
| 6118137100 | Cut Edge: 18.0 Millimeter | In distribution |
| 6113127075 | Cut Edge: 13.0 Millimeter | In distribution |
| 6118119100 | Material Thickness: 1.19 Millimeter | In distribution |
| 6118119090 | Material Thickness: 1.19 Millimeter | In distribution |
| 6221100090 | Depth 90.0 mm | In distribution |
| 6213137070 | Cut Edge: 13.0 Millimeter | In distribution |
| 6125097090 | Material Thickness: 0.97 Millimeter | In distribution |
| 6118127090 | Depth 90.0 mm | In distribution |
| 6125147090 | Material Thickness: 1.47 Millimeter | In distribution |
| 6113127090 | Depth 90.0 mm | In distribution |
| 6118119110 | Cut Edge: 18.0 Millimeter | In distribution |
| 6125089090 | Cut Edge: 25.0 Millimeter | In distribution |
| 6113137100 | Cut Edge: 13.0 Millimeter | In distribution |
| 6125119090 | Material Thickness: 1.19 Millimeter | In distribution |
| 6118127100 | Material Thickness: 1.27 Millimeter | In distribution |
| 6118089090 | Cut Edge: 18.0 Millimeter | In distribution |
| 6125137090 | Cut Edge: 25.0 Millimeter | In distribution |
| 6221119090 | Cut Edge: 21.0 Millimeter | In distribution |
| 6221147090 | Depth 90.0 mm | In distribution |
| 6125107090 | Cut Edge: 25.0 Millimeter | In distribution |
| 6113107090 | Cut Edge: 13.0 Millimeter | In distribution |
| 6125100110 | Cut Edge: 25.0 Millimeter | In distribution |
| 6113127100 | Material Thickness: 1.27 Millimeter | In distribution |
| 6125127100 | Depth 100.0 mm | In distribution |
| 6213119070 | Depth 70.0 mm | In distribution |
| 6221127090 | Depth 90.0 mm | In distribution |
| 6118147060 | Material Thickness: 1.47 Millimeter | In distribution |
| 6118097090 | Material Thickness: 0.97 Millimeter | In distribution |
| 6118089075 | Material Thickness: 0.89 Millimeter | In distribution |
| 6213127070 | Material Thickness: 1.27 Millimeter | In distribution |
| 6125089075 | Depth 75.0 mm | In distribution |
| 6221137090 | Depth 90.0 mm | In distribution |
| 6113147090 | Depth 90.0 mm | In distribution |
| 6118137090 | Material Thickness: 1.37 Millimeter | In distribution |
| 6118127110 | Cut Edge: 18.0 Millimeter | In distribution |
| 6125127090 | Cut Edge: 25.0 Millimeter | In distribution |
| 6113089090 | Material Thickness: 0.89 Millimeter | In distribution |
| 6113119090 | Depth 90.0 mm | In distribution |
| 6125137100 | Depth 100.0 mm | In distribution |
| 6118127075 | Cut Edge: 18.0 Millimeter | In distribution |
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 |
|---|---|---|---|---|---|
| 2019-03-19 | Class II | Under Investigation by firm | During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. | 355 | 2020-06-26 |
| 2011-06-13 | Not classified | Labeling mix-ups | Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle. | 95 Units | 2011-08-03 |
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.