Profyle
2.3mm Over Drill Bit, WL 26mm, Stryker-Shaft
27manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (12), Shanghai (5), Guangdong (4). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 27. All 27 manufacturers in China registered for Bit, Drill
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2025-04-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 36 to 108 mm |
| Distribution end date | 2022-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-19426 | Diameter: 1.9 Millimeter | In distribution |
| 60-80117 | Diameter: 1.7 Millimeter | In distribution |
| 60-14326 | Length 87.0 mm | In distribution |
| 60-10422 | Length 73.0 mm | In distribution |
| 60-80317 | Length 47.0 mm | In distribution |
| 60-80112 | Diameter: 1.2 Millimeter | In distribution |
| 60-20385 | Length 105.0 mm | In distribution |
| 60-80312 | Length 46.0 mm | In distribution |
| 92-23126 | Diameter: 2.3 Millimeter | In distribution |
| 92-60190 | Length 82.0 mm | In distribution |
| 60-19126 | Diameter: 94.0 Millimeter | In distribution |
| 07-30425 | In distribution | |
| 60-80123 | Length 55.0 mm | In distribution |
| 60-88317 | Diameter: 1.3 Millimeter | In distribution |
| 60-88123 | Diameter: 2.35 Millimeter | In distribution |
| 60-88312 | Diameter: 0.9 Millimeter | In distribution |
| 60-88112 | Diameter: 0.9 Millimeter | In distribution |
| 60-88117 | Diameter: 1.75 Millimeter | In distribution |
| 60-10415 | Diameter: 1.0 Millimeter | In distribution |
| 60-25426 | Length 77.0 mm | In distribution |
| 91-10322 | Diameter: 1.0 Millimeter | In distribution |
| 91-10415 | Diameter: 1.0 Millimeter | In distribution |
| 60-88323 | Diameter: 1.8 Millimeter | In distribution |
| 07-30426 | In distribution | |
| 60-25326 | Diameter: 2.5 Millimeter | In distribution |
| 60-88423 | Diameter: 2.35 Millimeter | In distribution |
| 60-10315 | Length 76.0 mm | In distribution |
| 60-10115 | Diameter: 1.0 Millimeter | In distribution |
| 62-23503 | Length 70.0 mm | In distribution |
| 60-14426 | Length 77.0 mm | In distribution |
| 60-80323 | Diameter: 2.3 Millimeter | In distribution |
| 60-80423 | Diameter: 2.3 Millimeter | In distribution |
| 60-88412 | Diameter: 0.9 Millimeter | In distribution |
| 60-19326 | Diameter: 1.9 Millimeter | In distribution |
| 62-17503 | Diameter: 1.7 Millimeter | In distribution |
| 60-80412 | Length 36.0 mm | In distribution |
| 60-80417 | Length 37.0 mm | In distribution |
| 62-12503 | Diameter: 1.2 Millimeter | In distribution |
| 92-60090 | Diameter: 0.9 Millimeter | In distribution |
| 60-88417 | Diameter: 1.3 Millimeter | In distribution |
| 91-10422 | Length 73.0 mm | In distribution |
| 07-30428 | In distribution | |
| 60-10122 | Length 90.0 mm | In distribution |
| 07-30427 | In distribution | |
| 92-60130 | Length 66.0 mm | In distribution |
| 60-25126 | Diameter: 2.5 Millimeter | In distribution |
| 92-17126 | Diameter: 1.7 Millimeter | In distribution |
| 91-19426 | Diameter: 1.9 Millimeter | In distribution |
| 60-14126 | Diameter: 1.4 Millimeter | In distribution |
| 60-10322 | Diameter: 1.0 Millimeter | In distribution |
| 91-14426 | Length 77.0 mm | In distribution |
| 60-19440 | Length 91.0 mm | Withdrawn |
| 60-20185 | Diameter: 2.0 Millimeter | Withdrawn |
| 60-19140 | Diameter: 1.9 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bit, Drill | Sterilmed, Inc. | 633 |
| Bit, Drill | Synthes Gmbh | 412 |
| Arthrex® | Arthrex, Inc. | 406 |
| Level ONE | KLS-Martin L.P. | 246 |
| Acumed | Acumed LLC | 205 |
| Stryker | Provision | 198 |
| Arthrex | Provision | 186 |
| Tecomet | Tecomet, Inc. | 166 |
| Synthes | Provision | 164 |
| Drill bit | Jeil Medical Corporation | 134 |
| Bit, Drill | AAP Implantate AG | 114 |
| Emerge Medical & Design | Emerge Technologies, Inc. | 110 |
Showing 12 of 1,958. All products under Bit, Drill
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.