Instrument, Surgical, Orthopedic, Ac-Powered Motor and Accessory/Attachment
DRILL BIT, QUICK CONNECT, MODIFIED HEX END, 101.6mm (4") LENGTH
23manufacturers in China registered for this device type
129catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | HWE |
| Device type | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-19 |
| Record revised | 2025-09-04 (version 2) |
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, serial number |
| Sizes | Outer diameter 43 to 70 mm; length 3 to 145 mm; length 3 to 5 in |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 183-01-60 | Outer Diameter 60 mm | In distribution |
| 183-01-62 | Outer Diameter 62 mm | In distribution |
| 123-00-38 | SIZE 38 | In distribution |
| 201-78-86 | Length 3 in | In distribution |
| 201-78-99 | Length 40 mm | In distribution |
| 123-00-53 | Outer Diameter 53 mm | In distribution |
| 151-00-23 | 1/4 inch | In distribution |
| 183-00-45 | SIZE 45 | In distribution |
| 183-00-56 | SIZE 56 | In distribution |
| 521-78-00 | In distribution | |
| 183-00-50 | SIZE 50 | In distribution |
| 201-78-63 | Length 101.6 mm | In distribution |
| 183-00-41 | SIZE 41 | In distribution |
| 123-00-46 | Outer Diameter 46 mm | In distribution |
| 201-78-82 | Length 40 mm | In distribution |
| 183-01-51 | Outer Diameter 51 mm | In distribution |
| 101-31-05 | 6.5mm | In distribution |
| 183-00-39 | SIZE 39 | In distribution |
| 123-00-44 | Outer Diameter 44 mm | In distribution |
| 183-00-68 | SIZE 68 | In distribution |
| 101-30-06 | 6.5mm | In distribution |
| 183-00-53 | SIZE 53 | In distribution |
| 01-003-07-0001 | In distribution | |
| 183-00-59 | SIZE 59 | In distribution |
| 123-00-51 | Outer Diameter 51 mm | In distribution |
| 123-00-55 | Outer Diameter 55 mm | In distribution |
| 183-00-43 | SIZE 43 | In distribution |
| 183-00-38 | SIZE 38 | In distribution |
| 183-01-56 | Outer Diameter 56 mm | In distribution |
| 183-00-58 | SIZE 58 | In distribution |
| 201-78-52 | In distribution | |
| 123-00-70 | Outer Diameter 70 mm | In distribution |
| 183-00-69 | SIZE 69 | In distribution |
| 123-00-42 | SIZE 42 | In distribution |
| 123-00-47 | Outer Diameter 47 mm | In distribution |
| 123-00-61 | Outer Diameter 61 mm | In distribution |
| 123-00-58 | Outer Diameter 58 mm | In distribution |
| 183-00-48 | SIZE 48 | In distribution |
| 123-00-45 | Outer Diameter 45 mm | In distribution |
| 123-00-48 | Outer Diameter 48 mm | In distribution |
| 123-00-54 | Outer Diameter 54 mm | In distribution |
| 183-01-48 | Outer Diameter 48 mm | In distribution |
| 183-01-50 | Outer Diameter 50 mm | In distribution |
| 183-01-57 | Outer Diameter 57 mm | In distribution |
| 183-01-46 | Outer Diameter 46 mm | In distribution |
| 201-78-98 | Length 130 mm | In distribution |
| 123-00-65 | Outer Diameter 65 mm | In distribution |
| 123-00-50 | Outer Diameter 50 mm | In distribution |
| 123-00-64 | Outer Diameter 64 mm | In distribution |
| 183-00-49 | SIZE 49 | In distribution |
| 123-00-59 | Outer Diameter 59 mm | In distribution |
| 101-30-01 | 4.5mm | In distribution |
| 183-00-67 | SIZE 67 | In distribution |
| 183-00-66 | SIZE 66 | In distribution |
| 183-01-65 | Outer Diameter 65 mm | In distribution |
| 183-01-63 | Outer Diameter 63 mm | In distribution |
| 101-30-03 | 6.5mm | In distribution |
| 123-00-40 | SIZE 40 | In distribution |
| 02-029-12-1200 | In distribution | |
| 183-01-47 | Outer Diameter 47 mm | In distribution |
| 181-65-02 | Size 6.5mm | In distribution |
| 201-78-62 | Length 101.6 mm | In distribution |
| 123-00-57 | Outer Diameter 57 mm | In distribution |
| 183-01-49 | Outer Diameter 49 mm | In distribution |
| 201-78-72 | Length 145 mm | In distribution |
| 183-00-62 | SIZE 62 | In distribution |
| 183-00-57 | SIZE 57 | In distribution |
| 123-00-60 | Outer Diameter 60 mm | In distribution |
| 183-01-53 | Outer Diameter 53 mm | In distribution |
| 123-00-67 | Outer Diameter 67 mm | In distribution |
| 183-00-63 | SIZE 63 | In distribution |
| 123-00-66 | Outer Diameter 66 mm | In distribution |
| 183-01-54 | Outer Diameter 54 mm | In distribution |
| 183-00-44 | SIZE 44 | In distribution |
| 183-00-64 | SIZE 64 | In distribution |
| 183-00-52 | SIZE 52 | In distribution |
| 183-01-64 | Outer Diameter 64 mm | In distribution |
| 123-00-68 | Outer Diameter 68 mm | In distribution |
| 183-01-66 | Outer Diameter 66 mm | In distribution |
| 183-01-55 | Outer Diameter 55 mm | In distribution |
| 201-78-81 | Length 3 in | In distribution |
| 123-00-43 | Outer Diameter 43 mm | In distribution |
| 183-00-40 | SIZE 40 | In distribution |
| 201-78-89 | Length 3 in | In distribution |
| 101-07-00 | In distribution | |
| 183-00-47 | SIZE 47 | In distribution |
| 201-78-64 | Length 76.2 mm | In distribution |
| 123-00-41 | SIZE 41 | In distribution |
| 123-00-49 | Outer Diameter 49 mm | In distribution |
| 201-78-78 | Length 4 in | In distribution |
| 123-00-62 | Outer Diameter 62 mm | In distribution |
| 201-78-56 | Length 76.2 mm | In distribution |
| 201-78-91 | Length 5 in | In distribution |
| 201-78-51 | In distribution | |
| 183-00-51 | SIZE 51 | In distribution |
| 101-30-08 | 6.5mm | In distribution |
| 183-00-42 | SIZE 42 | In distribution |
| 183-01-61 | Outer Diameter 61 mm | In distribution |
| 183-00-61 | SIZE 61 | In distribution |
| 183-01-52 | Outer Diameter 52 mm | In distribution |
| 181-65-02 | In distribution | |
| 183-01-59 | Outer Diameter 59 mm | In distribution |
| 101-31-01 | 4.5mm | In distribution |
| 201-78-55 | Length 3 in | In distribution |
| 2100-0160 | In distribution | |
| 201-78-88 | Length 4 in | In distribution |
| 101-30-07 | 4.5mm | In distribution |
| 123-00-52 | Outer Diameter 52 mm | In distribution |
| 101-31-03 | 6.5mm | In distribution |
| 123-00-63 | Outer Diameter 63 mm | In distribution |
| 183-00-55 | SIZE 55 | In distribution |
| 400-40-06 | In distribution | |
| 183-00-54 | SIZE 54 | In distribution |
| 201-78-87 | Length 4 in | In distribution |
| 123-00-56 | Outer Diameter 56 mm | In distribution |
| 183-00-46 | SIZE 46 | In distribution |
| 183-00-70 | SIZE 70 | In distribution |
| 201-78-80 | Length 3 in | In distribution |
| 123-00-39 | SIZE 39 | In distribution |
| 183-01-58 | Outer Diameter 58 mm | In distribution |
| 123-00-69 | Outer Diameter 69 mm | In distribution |
| 201-78-90 | Length 5 in | In distribution |
| 201-78-97 | Length 145 mm | In distribution |
| 201-78-74 | Length 130 mm | In distribution |
| 183-00-60 | SIZE 60 | In distribution |
| 183-00-65 | SIZE 65 | In distribution |
| 521-78-01 | Withdrawn | |
| 201-46-00 | Withdrawn | |
| 201-45-00 | 1/8 outer diameter 5 inch length | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZX | Imedicom Co., Ltd. | 441 |
| Arthrex® | Arthrex, Inc. | 391 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Stryker GmbH | 284 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 231 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Synthes Gmbh | 226 |
| Brasseler EZX | Imedicom Co., Ltd. | 187 |
| Conserve® | Microport Orthopedics Inc. | 158 |
| R3 | Smith & Nephew, Inc. | 147 |
| Trigen | Smith & Nephew, Inc. | 139 |
| MicroPort | Microport Orthopedics Inc. | 134 |
| Made-To-Order | Tornier Inc. | 131 |
| Profemur® | Microport Orthopedics Inc. | 129 |
Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960720 | 1996-04-23 |
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.