Chisel, Surgical, Manual
Bone Chisel Blunt Squared Handle Steel D 3.0mm, WL 310mm
10manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Zhejiang (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Record
| Listed by | Doppkon Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | FZO |
| Device type | Chisel, Surgical, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-100-655 | In distribution | |
| A-100-656 | In distribution | |
| A-100-659 | In distribution | |
| A-100-789 | In distribution | |
| A-100-683 | In distribution | |
| A-100-650 | In distribution | |
| A-100-068 | In distribution | |
| A-100-670 | In distribution | |
| A-100-669 | In distribution | |
| A-100-671 | In distribution | |
| A-100-642 | In distribution | |
| A-100-664 | In distribution | |
| A-100-643 | In distribution | |
| A-100-675 | In distribution | |
| A-100-676 | In distribution | |
| A-100-649 | In distribution | |
| A-100-684 | In distribution | |
| A-100-660 | In distribution | |
| A-100-682 | In distribution | |
| A-100-790 | In distribution | |
| A-100-666 | In distribution | |
| A-100-665 | In distribution | |
| A-100-644 | In distribution | |
| A-100-679 | In distribution | |
| A-100-681 | In distribution | |
| A-100-067 | In distribution | |
| A-100-651 | In distribution | |
| A-100-680 | In distribution | |
| A-100-776 | In distribution | |
| A-100-661 | In distribution | |
| A-100-069 | In distribution | |
| A-100-674 | In distribution | |
| A-100-777 | In distribution | |
| A-100-066 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surtex | Surtex Instruments Ltd | 297 |
| Sklar | Sklar Corporation | 175 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 119 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 96 |
| Ambler Surgical | Ambler Surgical, LLC | 95 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 87 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 60 |
| Boss Instruments | Boss Instruments, Ltd. | 52 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 50 |
| Aesculap | Aesculap AG | 42 |
| Kmedic | Teleflex Medical LLC | 41 |
| American Medicals | American Medicals | 41 |
Showing 12 of 179. All products under Chisel, Surgical, Manual
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.