Reprocessed Sagittal Saw Blade, Small Bone, 25.4 X 9.5 X 0.63mm
2 catalogue numbers from KM-3101, listed by Suretek Medical, United States, under Blade, Saw, General & Plastic Surgery, Surgical. 25 manufacturers in China are registered for this product 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 | Suretek Medical, 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 |
| Premarket notification | Exempt |
| Record published | 2021-05-20 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KM-3101 | In distribution | |
| KM-3102 | 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
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.