Level ONE
Twist Drill, J Notch, Morrison, 27 MM Stop, 25 MM Flute, FOR Drill Guide
27manufacturers in China registered for this device type
246catalogue 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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2025-12-08 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-04-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50-810-05-07 | 0.7 X 40 MM | In distribution |
| 26-153-20-07 | 2.1 X 75 MM | In distribution |
| 50-522-40-91 | 2.2 X 85 MM | In distribution |
| 50-997-05-07 | 1.9 X 13 MM | In distribution |
| 25-450-07-91 | 1.5 X 50 MM | In distribution |
| 25-449-11-91 | 1.5 X 50 MM | In distribution |
| 25-472-76-07 | 1.5 X 115 MM, 2.35 MM DIA | In distribution |
| 50-824-40-07 | 1.9 X 115 MM | In distribution |
| 25-451-08-91 | 1.1 X 61 MM | In distribution |
| 26-153-23-07 | 2.4 X 75 MM | In distribution |
| 25-457-05-91 | 0.8 X 50 MM | In distribution |
| 50-924-07-07 | 1.5 X 20 MM | In distribution |
| 25-463-23-91 | 1.5 X 85 MM | In distribution |
| 25-466-19-91 | 1.9 X 105 MM | In distribution |
| 25-447-12-91 | 1.2 X 61 MM | In distribution |
| 25-452-61-07 | 1.1 X 105 MM | In distribution |
| 26-153-08-07 | 0.8 X 50 MM | In distribution |
| 25-473-95-07 | 1.9 X 115 MM, 2.0 MM DIA | In distribution |
| 00-104-49-07 | 1.0 X 38 MM | In distribution |
| 25-473-70-07 | 1.5 X 105 MM, 4.0 MM DIA | In distribution |
| 25-460-18-91 | 1.8 X 70 MM | In distribution |
| 25-452-05-91 | 1.1 X 50 MM | In distribution |
| 01-451-00-07 | 1.1 X 50 MM | In distribution |
| 25-472-77-07 | 1.9 X 115 MM, 2.0 MM DIA | In distribution |
| 26-475-20-07 | 1.9/0.9 X 123 MM | In distribution |
| 26-158-15-07 | 1.5 X 73 MM | In distribution |
| 50-816-09-91 | 1.15 X 50 MM | In distribution |
| 50-997-19-07 | 1.9 X 27 MM | In distribution |
| 26-975-63-07 | 2.4 X 85 MM | In distribution |
| 50-815-07-07 | 1.1 X 40 MM | In distribution |
| 50-022-04-07 | 2.2 X 105 MM | In distribution |
| 01-065-01-07 | 1.5 X 26 MM | In distribution |
| 50-928-09-07 | 1.8 X 22 MM | In distribution |
| 01-451-63-07 | 1.5 X 115 MM | In distribution |
| 25-460-07-07 | 1.9 X 70 MM | In distribution |
| 50-996-07-07 | 1.5 X 15 MM | In distribution |
| 25-449-16-91 | 1.5 X 50 MM | In distribution |
| 25-454-05-91 | 0.7 X 50 MM | In distribution |
| 26-150-18-07 | 1.8 X 70 MM | In distribution |
| 25-469-11-07 | 1.5 X 115 MM | In distribution |
| 26-153-15-07 | 1.5 X 62 MM | In distribution |
| 25-460-19-07 | 1.9 X 70 MM | In distribution |
| 50-812-05-91 | 1.0 X 50 MM | In distribution |
| 25-451-57-91 | 1.1 X 105 MM | In distribution |
| 26-975-58-07 | 1.8 X 85 MM | In distribution |
| 50-924-05-07 | 1.5 X 20 MM | In distribution |
| 25-456-05-91 | 1.0 X 50 MM | In distribution |
| 26-975-55-07 | 1.5 X 85 MM | In distribution |
| 25-452-07-91 | 1.1 X 50 MM | In distribution |
| 50-030-37-04 | In distribution | |
| 50-996-11-07 | 1.5 X 19 MM | In distribution |
| 50-030-38-04 | In distribution | |
| 50-519-15-07 | 1.9 X 115 MM | In distribution |
| 26-153-18-07 | 1.8 X 75 MM | In distribution |
| 25-455-07-91 | 0.8 X 50 MM | In distribution |
| 50-823-40-07 | 1.9 X 70 MM | In distribution |
| 25-452-03-91 | 1.1 X 50 MM | In distribution |
| 25-448-22-91 | 1.5 X 71 MM | In distribution |
| 25-448-12-91 | 1.3 X 61 MM | In distribution |
| 50-022-03-07 | 2.2 X 105 MM | In distribution |
| 50-126-06-07 | 2.8 X 105 MM | In distribution |
| 25-469-09-07 | 1.5 X 115 MM | In distribution |
| 25-449-07-91 | 1.5 X 50 MM | In distribution |
| 25-449-05-91 | 1.5 X 50 MM | In distribution |
| 25-457-07-91 | 0.8 X 50 MM | In distribution |
| 50-812-07-91 | 1.0 X 50 MM | In distribution |
| 25-472-82-07 | 2.2 X 115 MM, 2.0 MM DIA | In distribution |
| 99-576-26-01 | 1.5 X 105 MM, 3.0 MM DIA | In distribution |
| 50-022-05-07 | In distribution | |
| 25-472-74-07 | 1.9 X 100 MM, 3.0 MM DIA | In distribution |
| 25-452-00-91 | 1.1 X 50 MM | In distribution |
| 01-473-71-07 | 1.5 X 117 MM, 4.0 MM DIA | In distribution |
| 25-472-70-07 | 1.5 X 100 MM, 3.0 MM DIA | In distribution |
| 26-475-10-07 | 1.9/0.9 X 123 MM | In distribution |
| 50-515-05-07 | 1.5 X 105 MM | In distribution |
| 92-250-75-07 | 1.1 X 87 MM | In distribution |
| 50-924-16-07 | 1.5 X 28 MM | In distribution |
| 50-820-09-07 | 1.5 X 40 MM | In distribution |
| 25-462-40-91 | 1.9 X 85 MM | In distribution |
| 25-464-19-91 | 1.9 X 70 MM | In distribution |
| 50-820-13-07 | In distribution | |
| 01-473-80-07 | 1.9 X 115 MM, 2.35 MM DIA | In distribution |
| 50-511-05-07 | 1.1 X 105 MM | In distribution |
| 25-448-06-91 | 1.5 X 20 MM | In distribution |
| 25-456-03-91 | 1.0 X 50 MM | In distribution |
| 26-158-10-07 | 1.0 X 70 MM | In distribution |
| 25-449-15-91 | 1.5 X 105 MM, 3.0 MM DIA | In distribution |
| 25-449-09-91 | 1.5 X 50 MM | In distribution |
| 50-812-04-91 | 1.0 X 50 MM | In distribution |
| 50-519-17-07 | In distribution | |
| 50-022-02-07 | 2.2 X 70 MM | In distribution |
| 25-462-19-91 | 1.9 X 105 MM | In distribution |
| 25-452-09-91 | 1.1 X 50 MM | In distribution |
| 26-460-20-07 | 2.3/1.1 X 123 MM | In distribution |
| 26-158-20-07 | 2.0 X 83 MM | In distribution |
| 25-452-57-07 | 1.1 X 105 MM | In distribution |
| 50-519-16-07 | 1.9 X 115 MM | In distribution |
| 50-022-01-07 | 2.2 X 70 MM | In distribution |
| 50-519-19-07 | In distribution | |
| 25-455-05-91 | 0.8 X 50 MM | In distribution |
| 50-996-17-07 | 1.5 X 25 MM | In distribution |
| 25-521-00-91 | 1.15 X 50 MM | In distribution |
| 26-975-44-07 | 1.0 X 62 MM | In distribution |
| 50-322-17-07 | 1.7-2.3 X 140 MM | In distribution |
| 25-472-73-07 | 1.5 X 100 MM, 3.0 MM DIA | In distribution |
| 995-4007-01 | 2.2 X 115 MM, 2.0 MM DIA | In distribution |
| 26-975-60-07 | 2.1 X 85 MM | In distribution |
| 26-152-11-07 | 1.1 X 50 MM | In distribution |
| 50-022-15-07 | 2.2 X 115 MM | In distribution |
| 50-924-00-07 | 1.5 X 34 MM | In distribution |
| 25-472-85-07 | 2.0 X 100 MM, 3.0 MM DIA | In distribution |
| 01-473-70-07 | 1.5 X 105 MM, 4.0 MM DIA | In distribution |
| 25-451-12-91 | 1.1 X 61 MM | In distribution |
| 50-916-07-07 | 0.7 X 20 MM | In distribution |
| 01-473-85-07 | 2.0 X 105 MM, 4.0 MM DIA | In distribution |
| 50-994-07-07 | 1.0 X 15 MM | In distribution |
| 25-521-09-91 | 1.15 X 50 MM | In distribution |
| 26-158-12-07 | 1.2 X 70 MM | In distribution |
| 26-460-10-07 | 2.3/1.1 X 123 MM | In distribution |
| 99-564-99-01 | 1.5 X 125 MM | In distribution |
| 50-820-77-07 | 1.5 X 70 MM | In distribution |
| 50-996-05-07 | 1.5 X 13 MM | In distribution |
| 01-450-17-07 | 1.5 X 115 MM | In distribution |
| 26-158-16-07 | 1.5 X 83 MM | In distribution |
| 26-158-18-07 | 1.8 X 83 MM | In distribution |
| 25-468-11-04 | 1.5 X 115 MM | In distribution |
| 25-454-03-91 | 0.7 X 50 MM | In distribution |
| 50-996-13-07 | 1.5 X 21 MM | In distribution |
| 50-928-00-07 | 1.8 X 34 MM | In distribution |
| 25-472-80-07 | 1.9 X 100 MM, 3.0 MM DIA | In distribution |
| 50-820-11-07 | 1.5 X 40 MM | In distribution |
| 50-812-03-91 | 1.0 X 50 MM | In distribution |
| 50-920-00-07 | 1.1 X 30 MM | In distribution |
| 26-153-11-07 | 1.1 X 62 MM | In distribution |
| 01-473-86-07 | 2.2 X 105 MM, 4.0 MM DIA | In distribution |
| 50-519-21-07 | 1.9 X 115 MM | In distribution |
| 50-820-05-07 | 1.5 X 40 MM | In distribution |
| 50-519-07-07 | 1.9 X 105 MM | In distribution |
| 26-153-16-07 | 1.5 X 75 MM | In distribution |
| 50-828-40-07 | 2.2 X 115 MM | In distribution |
| 25-456-07-91 | 1.0 X 50 MM | In distribution |
| 50-920-07-07 | 1.1 X 20 MM | In distribution |
| 50-812-13-91 | 1.0 X 50 MM | In distribution |
| 50-816-00-91 | 1.15 X 50 MM | In distribution |
| 50-996-15-07 | 1.5 X 23 MM | In distribution |
| 25-456-04-91 | 1.0 X 50 MM | In distribution |
| 25-451-07-91 | 1.1 X 50 MM | In distribution |
| 25-472-75-07 | 1.5 X 100 MM, 3.0 MM DIA | In distribution |
| 25-473-90-07 | 1.5 X 115 MM, 4.0 MM DIA | In distribution |
| 26-158-23-07 | 2.3 X 83 MM | In distribution |
| 26-153-10-07 | 1.0 X 50 MM | In distribution |
| 25-451-00-91 | 1.1 X 50 MM | In distribution |
| 25-473-85-07 | 2.0 X 105 MM, 4.0 MM DIA | In distribution |
| 25-473-80-07 | 1.9 X 105 MM, 4.0 MM DIA | In distribution |
| 50-917-05-07 | 0.8 X 18 MM | In distribution |
| 25-454-07-91 | 0.7 X 50 MM | In distribution |
| 01-924-00-07 | 2.2 X 34 MM | In distribution |
| 26-158-11-07 | 1.1 X 73 MM | In distribution |
| 25-456-13-91 | 1.0 X 50 MM | In distribution |
| 01-451-62-07 | In distribution | |
| 50-996-09-07 | 1.5 X 17 MM | In distribution |
| 50-815-05-07 | 1.1 X 40 MM | In distribution |
| 50-820-07-07 | 1.5 X 40 MM | In distribution |
| 25-462-18-91 | 1.8 X 105 MM | In distribution |
| 01-473-81-07 | In distribution | |
| 25-461-16-91 | 1.5 X 70 MM | In distribution |
| 25-472-81-07 | 2.2 X 115 MM | In distribution |
| 01-022-01-07 | 2.2 X 50 MM | In distribution |
| 50-816-05-91 | 1.15 X 50 MM | In distribution |
| 50-821-24-07 | 1.5 X 115 MM | In distribution |
| 25-521-05-91 | 1.15 X 50 MM | In distribution |
| 01-450-80-07 | 1.5 X 80 MM | In distribution |
| 25-521-07-91 | 1.15 X 50 MM | In distribution |
| 25-458-19-07 | 1.9 X 50 MM | In distribution |
| 26-975-51-07 | 1.1 X 85 MM | In distribution |
| 01-469-11-07 | 1.5 X 115 MM, 2.0 MM DIA | In distribution |
| 50-916-05-07 | 0.7 X 18 MM | In distribution |
| 50-924-09-07 | 1.5 X 22 MM | In distribution |
| 25-450-16-91 | 1.5 X 50 MM | In distribution |
| 50-820-24-07 | 1.5 X 50 MM | In distribution |
| 25-452-15-91 | 1.1 X 50 MM | In distribution |
| 50-816-07-91 | 1.15 X 50 MM | In distribution |
| 50-995-07-07 | 1.1 X 15 MM | In distribution |
| 01-452-00-07 | 1.1 X 70 MM | In distribution |
| 50-997-07-07 | 1.9 X 15 MM | In distribution |
| 25-458-16-91 | 1.5 X 70 MM | In distribution |
| 25-451-05-91 | 1.1 X 50 MM | In distribution |
| 25-448-04-91 | 1.5 X 59 MM | In distribution |
| 50-995-05-07 | 1.1 X 13 MM | In distribution |
| 25-460-09-07 | 1.9 X 70 MM | In distribution |
| 50-995-17-07 | 1.1 X 25 MM | In distribution |
| 50-971-00-07 | Withdrawn | |
| 26-151-11-07 | Withdrawn | |
| 01-460-21-07 | Withdrawn | |
| 50-979-05-07 | Withdrawn | |
| 50-975-11-07 | Withdrawn | |
| 52-113-08-07 | Withdrawn | |
| 995-3402-02 | Withdrawn | |
| 25-451-61-07 | 1.1 X 105 MM | Withdrawn |
| 51-535-51-07 | 1.1 X 19 MM | Withdrawn |
| 26-150-20-07 | Withdrawn | |
| 50-975-09-07 | Withdrawn | |
| 50-979-07-07 | Withdrawn | |
| 26-150-23-07 | Withdrawn | |
| 26-151-16-07 | Withdrawn | |
| 01-040-74-07 | Withdrawn | |
| 26-150-15-07 | Withdrawn | |
| 26-152-23-07 | Withdrawn | |
| 01-065-00-07 | Withdrawn | |
| 52-113-06-07 | Withdrawn | |
| 50-975-00-07 | Withdrawn | |
| 26-151-23-07 | Withdrawn | |
| 01-449-70-91 | Withdrawn | |
| 99-569-59-01 | Withdrawn | |
| 50-975-05-07 | Withdrawn | |
| 25-450-05-91 | Withdrawn | |
| 25-462-16-91 | 1.5 X 70 MM | Withdrawn |
| 50-975-15-07 | Withdrawn | |
| 01-519-14-07 | Withdrawn | |
| 26-150-11-07 | Withdrawn | |
| 26-152-18-07 | Withdrawn | |
| 26-151-20-07 | Withdrawn | |
| 50-975-13-07 | Withdrawn | |
| 25-453-07-91 | 0.7 X 50 MM | Withdrawn |
| 01-450-16-07 | Withdrawn | |
| 995-3266-01 | Withdrawn | |
| 26-150-16-07 | Withdrawn | |
| 50-026-04-07 | 2.0 X 105 MM | Withdrawn |
| 25-472-86-07 | Withdrawn | |
| 25-466-18-07 | 1.8 X 105 MM | Withdrawn |
| 25-453-05-91 | 0.7 X 50 MM | Withdrawn |
| 26-152-20-07 | Withdrawn | |
| 50-971-07-07 | Withdrawn | |
| 26-151-15-07 | Withdrawn | |
| 50-979-00-07 | Withdrawn | |
| 26-152-15-07 | Withdrawn | |
| 52-113-07-07 | Withdrawn | |
| 25-451-09-91 | Withdrawn | |
| 26-151-18-07 | Withdrawn | |
| 52-013-05-07 | Withdrawn | |
| 25-449-13-07 | Withdrawn | |
| 50-975-07-07 | Withdrawn | |
| 995-3330-02 | Withdrawn | |
| 26-152-16-07 | Withdrawn | |
| 995-3402-01 | Withdrawn | |
| 25-451-03-91 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bit, Drill | Sterilmed, Inc. | 633 |
| Bit, Drill | Synthes Gmbh | 412 |
| Arthrex® | Arthrex, Inc. | 406 |
| 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 |
| Aptus | Medartis 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.