Tandry Compression Screw System
Tandry Compression Screw System provides titanium-alloy screws and pins for fractures, osteotomies and bone fusion. The range includes cannulated compression screws from 2.8 to 7.5 mm in…
Tandry Compression Screw System provides titanium-alloy screws and pins for fractures, osteotomies and bone fusion. The range includes cannulated compression screws from 2.8 to 7.5 mm in diameter, plus a 2.0 mm compression screw and pin.
Screw lengths vary with diameter. The implants are Ti-6Al-4V alloy with an anodized surface.
Listed Item
5.5mm Compression Cannulated Screw, 105mm
Break-Off Pin Configuration
The 2.0 mm compression pin has a groove between the shaft and screw body. After placement, bending the shaft back and forth separates it at that groove, leaving the compression body in place. This break-off feature belongs to the pin configuration rather than every screw in the range.
31manufacturers in China registered for this device type
140catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Microware Precision Co., Ltd., Taiwan |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K220359 |
| Record published | 2024-05-31 |
| Record revised | 2025-02-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T04360-016 | In distribution | |
| T04280-016 | In distribution | |
| T04280-024 | In distribution | |
| T04550-105 | In distribution | |
| T04280-018 | In distribution | |
| T04470-036 | In distribution | |
| T04360-026 | In distribution | |
| T04550-025 | In distribution | |
| T04360-042 | In distribution | |
| T04470-080 | In distribution | |
| T04410-070 | In distribution | |
| T04280-020 | In distribution | |
| T04360-028 | In distribution | |
| T04750-075 | In distribution | |
| T04750-040 | In distribution | |
| T04280-028 | In distribution | |
| T0415-012 | In distribution | |
| T04750-115 | In distribution | |
| T04280-014 | In distribution | |
| T04410-042 | In distribution | |
| T0415-026 | In distribution | |
| T0415-024 | In distribution | |
| T04410-055 | In distribution | |
| T04470-038 | In distribution | |
| T04410-024 | In distribution | |
| T04360-022 | In distribution | |
| T0415-015 | In distribution | |
| T04550-035 | In distribution | |
| T04550-050 | In distribution | |
| T0415-016 | In distribution | |
| T04750-120 | In distribution | |
| T04470-085 | In distribution | |
| T04360-044 | In distribution | |
| T04360-040 | In distribution | |
| T04360-050 | In distribution | |
| T04410-016 | In distribution | |
| T04750-085 | In distribution | |
| T04360-024 | In distribution | |
| T04750-060 | In distribution | |
| T04470-070 | In distribution | |
| T04550-095 | In distribution | |
| T04410-044 | In distribution | |
| T04410-050 | In distribution | |
| T04470-028 | In distribution | |
| T04750-105 | In distribution | |
| T04470-042 | In distribution | |
| T04280-030 | In distribution | |
| T04470-060 | In distribution | |
| T04360-030 | In distribution | |
| T04550-080 | In distribution | |
| T04470-048 | In distribution | |
| T04470-050 | In distribution | |
| T04280-022 | In distribution | |
| T04470-032 | In distribution | |
| T04750-110 | In distribution | |
| T04470-055 | In distribution | |
| T04410-030 | In distribution | |
| T04360-036 | In distribution | |
| T04410-060 | In distribution | |
| T04470-022 | In distribution | |
| T04410-020 | In distribution | |
| T0415-030 | In distribution | |
| T04550-030 | In distribution | |
| T04750-065 | In distribution | |
| T04410-032 | In distribution | |
| T04280-010 | In distribution | |
| T04470-030 | In distribution | |
| T04410-075 | In distribution | |
| T04550-100 | In distribution | |
| T04410-036 | In distribution | |
| T04470-075 | In distribution | |
| T0415-008 | In distribution | |
| T0415-007 | In distribution | |
| T04550-090 | In distribution | |
| T04280-008 | In distribution | |
| T04360-020 | In distribution | |
| T04750-050 | In distribution | |
| T04750-055 | In distribution | |
| T04470-090 | In distribution | |
| T04410-026 | In distribution | |
| T04470-034 | In distribution | |
| T04360-048 | In distribution | |
| T04470-026 | In distribution | |
| T04280-009 | In distribution | |
| T04280-011 | In distribution | |
| T0415-022 | In distribution | |
| T04470-040 | In distribution | |
| T04410-065 | In distribution | |
| T04280-026 | In distribution | |
| T0415-018 | In distribution | |
| T04410-048 | In distribution | |
| T04360-046 | In distribution | |
| T04550-070 | In distribution | |
| T04410-018 | In distribution | |
| T0415-010 | In distribution | |
| T0415-011 | In distribution | |
| T0415-009 | In distribution | |
| T04360-060 | In distribution | |
| T04280-013 | In distribution | |
| T04550-060 | In distribution | |
| T0415-028 | In distribution | |
| T04550-055 | In distribution | |
| T04410-034 | In distribution | |
| T0415-020 | In distribution | |
| T04750-090 | In distribution | |
| T04550-085 | In distribution | |
| T04410-038 | In distribution | |
| T04410-028 | In distribution | |
| T04550-065 | In distribution | |
| T04550-110 | In distribution | |
| T04470-024 | In distribution | |
| T04360-018 | In distribution | |
| T04470-046 | In distribution | |
| T04360-034 | In distribution | |
| T04360-055 | In distribution | |
| T04410-040 | In distribution | |
| T04750-045 | In distribution | |
| T04470-065 | In distribution | |
| T04750-080 | In distribution | |
| T04410-022 | In distribution | |
| T0415-013 | In distribution | |
| T04550-040 | In distribution | |
| T04360-038 | In distribution | |
| T04750-095 | In distribution | |
| T0415-014 | In distribution | |
| T04470-095 | In distribution | |
| T04280-015 | In distribution | |
| T04410-046 | In distribution | |
| T04550-075 | In distribution | |
| T04470-110 | In distribution | |
| T04750-070 | In distribution | |
| T04750-100 | In distribution | |
| T04470-105 | In distribution | |
| T04470-100 | In distribution | |
| T0415-006 | In distribution | |
| T04470-044 | In distribution | |
| T04470-020 | In distribution | |
| T04360-032 | In distribution | |
| T04550-045 | In distribution | |
| T04280-012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220359 | 2022-09-20 |
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.