Tandry Locking Plate System
Tandry is a system of anatomical bone plates, screws and surgical instruments for fracture fixation, fusion and osteotomy. Its plates accept locking, cortex, shaft and cancellous screws,…
Tandry is a system of anatomical bone plates, screws and surgical instruments for fracture fixation, fusion and osteotomy. Its plates accept locking, cortex, shaft and cancellous screws, allowing the fixation construct to be assembled for the treated bone.
The screws are self-tapping. Plate options include commercially pure titanium and titanium alloy, with different sizes and lengths for small bones, long bones and selected other anatomical regions.
Listed Item
3.5mm Locking Anterolateral Distal Tibial Plate, 15 Holes, Right
Plate Families
The 1.5 and 2.0 mm plate ranges are intended for selected hand and foot bones, while larger plate families address regions including the radius, ulna, humerus, pelvis, tibia and femur. The hip plate system is specifically intended for proximal femoral fractures; plate selection follows its anatomical indication.
22manufacturers in China registered for this device type
263catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Microware Precision Co., Ltd., Taiwan |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K230690 |
| Record published | 2025-09-15 |
| Record revised | 2025-11-20 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T2-436-504 | In distribution | |
| T2-04-112-019 | In distribution | |
| T2-441-690 | In distribution | |
| T2-04-114-002 | In distribution | |
| T2-04-111-641 | In distribution | |
| T2-441-272 | In distribution | |
| T2-441-903 | In distribution | |
| T2-04-112-011 | In distribution | |
| T2-04-114- 010 | In distribution | |
| T2-04-112-136 | In distribution | |
| T2-441-447 | In distribution | |
| T2-441-086 | In distribution | |
| T2-441-286 | In distribution | |
| T2-424-591 | In distribution | |
| T2-04-112-084 | In distribution | |
| T2-436-502 | In distribution | |
| T2-04-112-145 | In distribution | |
| T2-426-581 | In distribution | |
| T2-441-450 | In distribution | |
| T2-441-454 | In distribution | |
| T2-04-112-530 | In distribution | |
| T2-441-288 | In distribution | |
| T2-441-095 | In distribution | |
| T2-439-984 | In distribution | |
| T2-440-047 | In distribution | |
| T2-04-224-226 | In distribution | |
| T2-04-112-515 | In distribution | |
| T2-426-651 | In distribution | |
| T2-424-541 | In distribution | |
| T2-441-904 | In distribution | |
| T2-04-112-143 | In distribution | |
| T2-445-182 | In distribution | |
| T2-441-096 | In distribution | |
| T2-441-902 | In distribution | |
| T2-04-112-010 | In distribution | |
| T2-04-112-085 | In distribution | |
| T2-439-992 | In distribution | |
| T2-04-112-142 | In distribution | |
| T2-441-074 | In distribution | |
| T2-04-112-523 | In distribution | |
| T2-04-112-526 | In distribution | |
| T2-04-111-701 | In distribution | |
| T2-04-112-141 | In distribution | |
| T2-440-036 | In distribution | |
| T2-04-111-630 | In distribution | |
| T2-447-345 | In distribution | |
| T2-441-274 | In distribution | |
| T2-04-112-148 | In distribution | |
| T2-441-361 | In distribution | |
| T2-441-681 | In distribution | |
| T2-04-112-012 | In distribution | |
| T2-04-112-080 | In distribution | |
| T2-441-284 | In distribution | |
| T2-04-112-522 | In distribution | |
| T2-445-072 | In distribution | |
| T2-439-991 | In distribution | |
| T2-441-683 | In distribution | |
| T2-04-111-640 | In distribution | |
| T2-440-041 | In distribution | |
| T2-426-571 | In distribution | |
| T2-04-112-081 | In distribution | |
| T2-424-621 | In distribution | |
| T2-424-641 | In distribution | |
| T2-04-114-009 | In distribution | |
| T2-424-571 | In distribution | |
| T2-04-111-660 | In distribution | |
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| T2-04-112-137 | In distribution | |
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| T2-04-224-222 | In distribution | |
| T2-441-456 | In distribution | |
| T2-441-901 | In distribution | |
| T2-442-494 | In distribution | |
| T2-04-112-083 | In distribution | |
| T2-04-224-225 | In distribution | |
| T2-422-250 | In distribution | |
| T2-423-601 | In distribution | |
| T2-441-611 | In distribution | |
| T2-445-142 | In distribution | |
| T2-441-278 | In distribution | |
| T2-424-531 | In distribution | |
| T2-04-112-153 | In distribution | |
| T2-04-112-511 | In distribution | |
| T2-04-112-519 | In distribution | |
| T2-439-987 | In distribution | |
| T2-441-381 | In distribution | |
| T2-436-508 | In distribution | |
| T2-439-993 | In distribution | |
| T2-445-082 | In distribution | |
| T2-441-275 | In distribution | |
| T2-04-224-223 | In distribution | |
| T2-441-691 | In distribution | |
| T2-440-043 | In distribution | |
| T2-422-253 | In distribution | |
| T2-04-111-620 | In distribution | |
| T2-436-503 | In distribution | |
| T2-442-492 | In distribution | |
| T2-04-111-661 | In distribution | |
| T2-439-988 | In distribution | |
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| T2-426-631 | In distribution | |
| T2-04-111-680 | In distribution | |
| T2-04-111-621 | In distribution | |
| T2-441-289 | In distribution | |
| T2-04-224-234 | In distribution | |
| T2-441-685 | In distribution | |
| T2-04-111-700 | In distribution | |
| T2-445-092 | In distribution | |
| T2-04-112-020 | In distribution | |
| T2-423-611 | In distribution | |
| T2-04-112-146 | In distribution | |
| T2-440-040 | In distribution | |
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| T2-04-114-008 | In distribution | |
| T2-423-561 | In distribution | |
| T2-447-344 | In distribution | |
| T2-440-044 | In distribution | |
| T2-426-681 | In distribution | |
| T2-04-224-236 | In distribution | |
| T2-440-042 | In distribution | |
| T2-441-277 | In distribution | |
| T2-441-443 | In distribution | |
| T2-441-421 | In distribution | |
| T2-04-111-681 | In distribution | |
| T2-441-906 | In distribution | |
| T2-439-989 | In distribution | |
| T2-447-348 | In distribution | |
| T2-04-114-007 | In distribution | |
| T2-04-112-018 | In distribution | |
| T2-447-349 | In distribution | |
| T2-440-037 | In distribution | |
| T2-445-102 | In distribution | |
| T2-441-087 | In distribution | |
| T2-445-062 | In distribution | |
| T2-422-251 | In distribution | |
| T2-04-224-238 | In distribution | |
| T2-04-112-138 | In distribution | |
| T2-423-591 | In distribution | |
| T2-441-442 | In distribution | |
| T2-439-986 | In distribution | |
| T2-441-451 | In distribution | |
| T2-424-661 | In distribution | |
| T2-439-994 | In distribution | |
| T2-441-452 | In distribution | |
| T2-441-076 | In distribution | |
| T2-04-112-007 | In distribution | |
| T2-426-601 | In distribution | |
| T2-441-283 | In distribution | |
| T2-424-561 | In distribution | |
| T2-422-259 | In distribution | |
| T2-441-455 | In distribution | |
| T2-441-448 | In distribution | |
| T2-04-112-527 | In distribution | |
| T2-426-611 | In distribution | |
| T2-424-551 | In distribution | |
| T2-441-094 | In distribution | |
| T2-424-701 | In distribution | |
| T2-426-561 | In distribution | |
| T2-04-112-021 | In distribution | |
| T2-426-641 | In distribution | |
| T2-424-611 | In distribution | |
| T2-441-445 | In distribution | |
| T2-04-112-156 | In distribution | |
| T2-422-254 | In distribution | |
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| T2-04-114-014 | In distribution | |
| T2-441-401 | In distribution | |
| T2-440-038 | In distribution | |
| T2-423-571 | In distribution | |
| T2-426-661 | In distribution | |
| T2-422-255 | In distribution | |
| T2-441-453 | In distribution | |
| T2-441-449 | In distribution | |
| T2-04-112-518 | In distribution | |
| T2-441-285 | In distribution | |
| T2-04-111-650 | In distribution | |
| T2-04-224-224 | In distribution | |
| T2-04-112-531 | In distribution | |
| T2-441-321 | In distribution | |
| T2-04-111-631 | In distribution | |
| T2-440-045 | In distribution | |
| T2-442-491 | In distribution | |
| T2-445-052 | In distribution | |
| T2-441-680 | In distribution | |
| T2-447-615 | In distribution | |
| T2-04-112-157 | In distribution | |
| T2-441-097 | In distribution | |
| T2-441-441 | In distribution | |
| T2-04-112-152 | In distribution | |
| T2-422-257 | In distribution | |
| T2-424-581 | In distribution | |
| T2-426-591 | In distribution | |
| T2-04-114-006 | In distribution | |
| T2-423-581 | In distribution | |
| T2-441-684 | In distribution | |
| T2-04-114-004 | In distribution | |
| T2-04-112-009 | In distribution | |
| T2-04-224-230 | In distribution | |
| T2-441-341 | In distribution | |
| T2-04-112-082 | In distribution | |
| T2-436-505 | In distribution | |
| T2-441-331 | In distribution | |
| T2-436-507 | In distribution | |
| T2-445-202 | In distribution | |
| T2-423-621 | In distribution | |
| T2-445-122 | In distribution | |
| T2-447-346 | In distribution | |
| T2-426-621 | In distribution | |
| T2-04-114-005 | In distribution | |
| T2-424-681 | In distribution | |
| T2-441-610 | In distribution | |
| T2-441-276 | In distribution | |
| T2-04-112-149 | In distribution | |
| T2-04-114-003 | In distribution | |
| T2-442-493 | In distribution | |
| T2-439-990 | In distribution | |
| T2-04-112-147 | In distribution | |
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| T2-04-111-651 | In distribution | |
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| T2-04-224-228 | In distribution | |
| T2-424-521 | In distribution | |
| T2-441-682 | In distribution | |
| T2-441-692 | In distribution | |
| T2-04-112-161 | In distribution | |
| T2-436-506 | In distribution | |
| T2-04-112-013 | In distribution | |
| T2-441-282 | In distribution | |
| T2-447-347 | In distribution | |
| T2-423-551 | In distribution | |
| T2-441-287 | In distribution | |
| T2-424-601 | In distribution | |
| T2-441-351 | In distribution | |
| T2-441-440 | In distribution | |
| T2-441-279 | In distribution | |
| T2-04-112-144 | In distribution | |
| T2-426-671 | In distribution | |
| T2-04-112-510 | In distribution | |
| T2-441-371 | In distribution | |
| T2-439-985 | In distribution | |
| T2-441-085 | In distribution | |
| T2-441-620 | In distribution | |
| T2-04-112-140 | In distribution |
Showing 250 of 263 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242814 | 2024-11-14 |
| K230690 | 2023-08-17 |
| K171904 | 2018-09-18 |
| K111008 | 2012-05-02 |
| K072562 | 2008-12-04 |
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.