Titan™
Titan™ Reverse Shoulder System The cannulated drill for 25mm central peg is used with the reverse shoulder system.
27manufacturers in China registered for this device type
20catalogue 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 |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRL-0920-080-001 | .320 in major dia;.705 in L thread | In distribution |
| DRL-0926-018-S | Medium/Large | In distribution |
| DRL096005425 | 2.24 in L;.925 in thread | In distribution |
| DRS-0926-001 | In distribution | |
| DL0920047002 | .207 in W tip | In distribution |
| DL0920047001 | .195 in W tip | In distribution |
| DRL-0926-002 | In distribution | |
| DRG-0926-001 | 1.25 in L x.960 in W | In distribution |
| DRG-0926-002 | X-Small/Small | In distribution |
| DRL096005415 | 1.83 in L;.516 in thread | In distribution |
| DRL096007501 | .320 in major dia;.424 in L thread | In distribution |
| DL0920056001 | .195 in W tip | In distribution |
| DRL-0923-047-001 | .320 in major dia;.640 in L flute | In distribution |
| DRL-0926-015-C | X-Small/Small | In distribution |
| DDG096007701 | 6.00 in L | In distribution |
| DRL-0926-015-S | X-Small/Small | In distribution |
| DRL-0926-018-C | Medium/Large | In distribution |
| DRL092208001 | .312 in major dia;.705 in L thread | In distribution |
| DRL-0926-001 | In distribution | |
| DRG-0926-003 | Medium/Large | In distribution |
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.