Integra®
Integra® Total Foot System The drill bit is a cutting tool used to create cylindrical holes. This drill bit is made for a Stryker fitting.
27manufacturers in China registered for this device type
19catalogue 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 | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-08-30 |
| Record revised | 2023-01-25 (version 7) |
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, expiry date |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CTD90002 | Size 2;.406 in W | In distribution |
| DRLTFS27 | 120 mm L x 2.7 mm dia | In distribution |
| 502 015207 | In distribution | |
| 12224029 | 8.660 in total L; 2.45 in tip L x.163 in tip dia | In distribution |
| DRLTFS35 | 135 mm L x 3.5 mm dia | In distribution |
| DRL096006801 | 6.0 in L x.110 in dia tip | In distribution |
| CTD90003 | Size 3;.456 in W | In distribution |
| DRLTFS25 | 135 mm L x 2.5 mm dia | In distribution |
| 12224027 | 8.660 in total L; 2.05 in tip L x.102 in tip dia | In distribution |
| 12224028 | 8.660 in total L; 2.45 in tip L x.124 in tip dia | In distribution |
| DRL096006101 | 6.0 in L x.098 in dia tip | In distribution |
| CTD90001 | Size 1;.356 in W | In distribution |
| DRLTFS15 | 120 mm L x 1.5 mm dia | In distribution |
| DRLTFS18 | 120 mm L x 1.8 mm dia | In distribution |
| 503 003545 | Withdrawn | |
| 8053-023NS | 2.5 mm x 180 mm | Withdrawn |
| 502 015136 | 2.5 x 94mm | Withdrawn |
| 8053-021NS | 2.0 mm x 125 mm | Withdrawn |
| 8053-025NS | 2.5 mm x 110 mm | 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.