Bit, Drill
Instrument 8796912 Zphr 13M Drlbt Triflt
27manufacturers in China registered for this device type
76catalogue 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2023-09-24 |
| Record revised | 2023-07-13 (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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Outer diameter 1.5 mm |
| Distribution end date | 2026-04-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6474176 | In distribution | |
| X0299-040 | In distribution | |
| 7756131 | In distribution | |
| 7080613 | 13mm | In distribution |
| 6630911 | 11mm | In distribution |
| 6630901 | 11mm | In distribution |
| 7080513 | In distribution | |
| 853-602 | 1.9mm | In distribution |
| 8796912 | In distribution | |
| 876-455 | In distribution | |
| 6961241 | In distribution | |
| G360T0320 | In distribution | |
| 6860470 | In distribution | |
| 876-455 | In distribution | |
| 5580164 | In distribution | |
| EX0915030 | In distribution | |
| 3034000 | In distribution | |
| 7730903 | In distribution | |
| 9870005 | 3.5mm | In distribution |
| EX0117023 | In distribution | |
| EX0216031 | 2.4mm | In distribution |
| 7756281S | In distribution | |
| 6630910 | 9mm | In distribution |
| X1009015 | 3.0mm | In distribution |
| 6860465 | In distribution | |
| 7730903 | In distribution | |
| 876-443 | In distribution | |
| 6905709 | 14mm | In distribution |
| X1210047 | In distribution | |
| 6860443 | In distribution | |
| 876-443 | In distribution | |
| 7730901 | 9mm | In distribution |
| 8530605 | 1.9mm | In distribution |
| 6905711 | In distribution | |
| 8796913 | In distribution | |
| 7756281 | 3.2mm | In distribution |
| 876-470 | In distribution | |
| X0299-042 | In distribution | |
| 7756007 | 2.4mm | In distribution |
| 7080510 | In distribution | |
| 6905710 | In distribution | |
| 3034001 | In distribution | |
| 7080610 | In distribution | |
| X876-943 | In distribution | |
| 6975150 | Outer Diameter 1.5 mm | In distribution |
| 7080610 | 11mm | In distribution |
| X0411333 | In distribution | |
| 7756010 | 2.4mm | In distribution |
| X1009017 | 4.0mm | In distribution |
| 7756133 | 3.2mm | In distribution |
| X6860443 | In distribution | |
| 7080510 | 11mm | In distribution |
| 873-007 | In distribution | |
| X0216055 | In distribution | |
| 7080613 | In distribution | |
| X0299-039 | In distribution | |
| X1009016 | 3.5mm | In distribution |
| 9098040 | In distribution | |
| G3600321 | In distribution | |
| 6630902 | In distribution | |
| 6975015 | Outer Diameter 1.5 mm | In distribution |
| 6860455 | In distribution | |
| G3600320 | In distribution | |
| G3606010 | In distribution | |
| 7080513 | 13mm | In distribution |
| EX0615091 | In distribution | |
| 3034001 | In distribution | |
| 876-955 | In distribution | |
| EX0316055 | In distribution | |
| 6630912 | 13mm | Withdrawn |
| X0901043 | Withdrawn | |
| X1006259 | Withdrawn | |
| X1010147 | 2.4mm | Withdrawn |
| X0308004 | Withdrawn | |
| X0299-041 | Withdrawn | |
| X0510056 | 13mm | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | UDI-DI | 2017-12-22 | Class II | Process control | Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification. | 2 units | 2018-07-31 |
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.