Armar™ / Artis™
ARMAR and ARTIS are bone plate ranges used with matching screws for temporary internal fixation. A plate spans the bone segments, and screws secure the construct during healing of fractures…
ARMAR and ARTIS are bone plate ranges used with matching screws for temporary internal fixation. A plate spans the bone segments, and screws secure the construct during healing of fractures or osteotomies.
The plate families include small-fragment, calcaneal, humeral and olecranon configurations within the Meril trauma platform. Different shapes and lengths accommodate the anatomical fixation site.
Listed Item
2.7mm/3.5mm Posterolateral Distal Humerus Plate, with Lateral Support, Right – The Bone Plate is composed of individually packaged plate designed for internal fixation, stabilization, reconstruction and support of fractured bone fracture. The Bone Plates are thin metal plates manufactured from Titanium-6Aluminium-7Niobium Alloy (TAN) complies with ISO 5832-11/ASTM F1295, titanium grade 4 (TiCP) complies with ASTM F67 / EN ISO 5832-2 and 18Chromium-14Nickel 2.5Molybdenum Stainless Steel (SS 316L & SS316LVM) complies with ASTM F138 and ASTM F139/ EN ISO 5832-1 and are used to reconstruct a bone that has been fractured. They immobilize the bone segments. For severe fractures, bone plates are surgically implanted to hold the bone in place. The plate is affixed with screws to properly align the bone and aid in the healing process.
Implants and Instruments
The platform uses medical-grade stainless steel and titanium implant options. Implants are single use and supplied nonsterile, while the separate placement instruments are reusable and also supplied nonsterile for steam sterilization.
22manufacturers in China registered for this device type
558catalogue numbers in this listing
1510(k) clearance
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 | Meril Healthcare PVT. Ltd., India |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K171320 |
| Record published | 2026-07-18 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MT-PT1412197L | In distribution | |
| MT-PS0611134 | In distribution | |
| MT-PT0906138R | In distribution | |
| MT-PT2004063R | In distribution | |
| MT-PT4202049R | In distribution | |
| MT-PT2618332 | In distribution | |
| MT-PT2611206 | In distribution | |
| MT-PS5412206 | In distribution | |
| MT-PS3607124 | In distribution | |
| MT-PT2115069R | In distribution | |
| MT-PS6114238 | In distribution | |
| MT-PS2509116 | In distribution | |
| MT-PT1107122L | In distribution | |
| MT-PT2005074L | In distribution | |
| MT-PS0610122 | In distribution | |
| MT-PS5604078 | In distribution | |
| MT-PT0912216L | In distribution | |
| MT-PT4114302L | In distribution | |
| MT-PT1205080R | In distribution | |
| MT-PT1106108L | In distribution | |
| MT-PT5005064 | In distribution | |
| MT-PS6003062 | In distribution | |
| MT-PS5803062 | In distribution | |
| MT-PS5603062 | In distribution | |
| MT-PT1812168 | In distribution | |
| MT-PS5414238 | In distribution | |
| MT-PT0720238 | In distribution | |
| MT-PT0305090L | In distribution | |
| MT-PT1509106 | In distribution | |
| MT-PT4406015R | In distribution | |
| MT-PS3610178 | In distribution | |
| MT-PS5610174 | In distribution | |
| MT-PT0314208R | In distribution | |
| MT-PT0709106 | In distribution | |
| MT-PT1608112 | In distribution | |
| MT-PT1712185L | In distribution | |
| MT-PT1406119R | In distribution | |
| MT-PT3012212 | In distribution | |
| MT-PT1710159R | In distribution | |
| MT-PT2915278 | In distribution | |
| MT-PT2706117L | In distribution | |
| MT-PS3916274 | In distribution | |
| MT-PT1809126 | In distribution | |
| MT-PT2006085R | In distribution | |
| MT-PS3710178 | In distribution | |
| MT-PT4613316L | In distribution | |
| MT-PS6006110 | In distribution | |
| MT-PT2612224 | In distribution | |
| MT-PT0813176 | In distribution | |
| MT-PT2705101R | In distribution | |
| MT-PS2510129 | In distribution | |
| MT-PT4407018L | In distribution | |
| MT-PT1822308 | In distribution | |
| MT-PT3003068 | In distribution | |
| MT-PT0107110L | In distribution | |
| MT-PS6014238 | In distribution | |
| MT-PT4407015R | In distribution | |
| MT-PS6108142 | In distribution | |
| MT-PS5902046 | In distribution | |
| MT-PT2922404 | In distribution | |
| MT-PS5614238 | In distribution | |
| MT-PT0411262 | In distribution | |
| MT-PT0103058L | In distribution | |
| MT-PS6212206 | In distribution | |
| MT-PS5808142 | In distribution | |
| MT-PS3906114 | In distribution | |
| MT-PS5905094 | In distribution | |
| MT-PS0605062 | In distribution | |
| MT-PT5304057R | In distribution | |
| MT-PT2003052R | In distribution | |
| MT-PT1006094L | In distribution | |
| MT-PT1215210R | In distribution | |
| MT-PT4406012R | In distribution | |
| MT-PS5912206 | In distribution | |
| MT-PT0103058R | In distribution | |
| MT-PS0603038 | In distribution | |
| MT-PT0722262 | In distribution | |
| MT-PT0408208 | In distribution | |
| MT-PS5705094 | In distribution | |
| MT-PT4404012L | In distribution | |
| MT-PT2115081R | In distribution | |
| MT-PS5404078 | In distribution | |
| MT-PT4404015L | In distribution | |
| MT-PT2622404 | In distribution | |
| MT-PT2918332 | In distribution | |
| MT-PS5416270 | In distribution | |
| MT-PT0203055L | In distribution | |
| MT-PT2909170 | In distribution | |
| MT-PS5502046 | In distribution | |
| MT-PT4405018R | In distribution | |
| MT-PT4203040R | In distribution | |
| MT-PS5805094 | In distribution | |
| MT-PT0309143R | In distribution | |
| MT-PT5305066R | In distribution | |
| MT-PT2902044 | In distribution | |
| MT-PT5210232 | In distribution | |
| MT-PT5304057L | In distribution | |
| MT-PT5012148 | In distribution | |
| MT-PT2908152 | In distribution | |
| MT-PT1606086 | In distribution | |
| MT-PS5518302 | In distribution | |
| MT-PT4807180L | In distribution | |
| MT-PT1221288L | In distribution | |
| MT-PT2617314 | In distribution | |
| MT-PS5505094 | In distribution | |
| MT-PS5903062 | In distribution | |
| MT-PS6002046 | In distribution | |
| MT-PT4406015L | In distribution | |
| MT-PS5812206 | In distribution | |
| MT-PT1416249R | In distribution | |
| MT-PT4203043R | In distribution | |
| MT-PT0415334 | In distribution | |
| MT-PT3010180 | In distribution | |
| MT-PT1213184L | In distribution | |
| MT-PT0205090L | In distribution | |
| MT-PT4405015R | In distribution | |
| MT-PT4203043L | In distribution | |
| MT-PS2518233 | In distribution | |
| MT-PT0209143R | In distribution | |
| MT-PT4905085 | In distribution | |
| MT-PS5405094 | In distribution | |
| MT-PS5804078 | In distribution | |
| MT-PT2606116 | In distribution | |
| MT-PT2608152 | In distribution | |
| MT-PS6202046 | In distribution | |
| MT-PT4609236L | In distribution | |
| MT-PS3612214 | In distribution | |
| MT-PS6216270 | In distribution | |
| MT-PS5516270 | In distribution | |
| MT-PT1818252 | In distribution | |
| MT-PS3704070 | In distribution | |
| MT-PS3615268 | In distribution | |
| MT-PT5305061R | In distribution | |
| MT-PS3616286 | In distribution | |
| MT-PS3614250 | In distribution | |
| MT-PT0822293 | In distribution | |
| MT-PT1404093R | In distribution | |
| MT-PS0612146 | In distribution | |
| MT-PT0716190 | In distribution | |
| MT-PT1215210L | In distribution | |
| MT-PT0809124 | In distribution | |
| MT-PT1513158 | In distribution | |
| MT-PT2905098 | In distribution | |
| MT-PT1209132R | In distribution | |
| MT-PT4805140R | In distribution | |
| MT-PS3705088 | In distribution | |
| MT-PT1211158L | In distribution | |
| MT-PT1104081R | In distribution | |
| MT-PT4708161R | In distribution | |
| MT-PT5303048R | In distribution | |
| MT-PT5303047L | In distribution | |
| MT-PT0405154 | In distribution | |
| MT-PT0404136 | In distribution | |
| MT-PT2704085L | In distribution | |
| MT-PT2907134 | In distribution | |
| MT-PT0305090R | In distribution | |
| MT-PS6110174 | In distribution | |
| MT-PT0114201L | In distribution | |
| MT-PS3720358 | In distribution | |
| MT-PT1811154 | In distribution | |
| MT-PT2613242 | In distribution | |
| MT-PT0214208L | In distribution | |
| MT-PT1807098 | In distribution | |
| MT-PT2609170 | In distribution | |
| MT-PS3912210 | In distribution | |
| MT-PT1418275L | In distribution | |
| MT-PT0910190R | In distribution | |
| MT-PT4406018R | In distribution | |
| MT-PT1207106R | In distribution | |
| MT-PT4706135L | In distribution | |
| MT-PT4714239L | In distribution | |
| MT-PT1207106L | In distribution | |
| MT-PT2610188 | In distribution | |
| MT-PT1209132L | In distribution | |
| MT-PT1420301L | In distribution | |
| MT-PT4110230R | In distribution | |
| MT-PT1805070 | In distribution | |
| MT-PT2703069R | In distribution | |
| MT-PS3914242 | In distribution | |
| MT-PT1007110L | In distribution | |
| MT-PS5503062 | In distribution | |
| MT-PT4112266L | In distribution | |
| MT-PT5206160 | In distribution | |
| MT-PS5814238 | In distribution | |
| MT-PT2615278 | In distribution | |
| MT-PS2502025 | In distribution | |
| MT-PT1219262L | In distribution | |
| MT-PS5504078 | In distribution | |
| MT-PT1103069R | In distribution | |
| MT-PT4407018R | In distribution | |
| MT-PT1612164 | In distribution | |
| MT-PT4407012L | In distribution | |
| MT-PT0820267 | In distribution | |
| MT-PT4807180R | In distribution | |
| MT-PT4714239R | In distribution | |
| MT-PS0602026 | In distribution | |
| MT-PT0811150 | In distribution | |
| MT-PS3722394 | In distribution | |
| MT-PT1304104 | In distribution | |
| MT-PT4809220R | In distribution | |
| MT-PT4405015L | In distribution | |
| MT-PT5303043R | In distribution | |
| MT-PT1211158R | In distribution | |
| MT-PS6004078 | In distribution | |
| MT-PS3918306 | In distribution | |
| MT-PT0806085 | In distribution | |
| MT-PT2115076L | In distribution | |
| MT-PT0816215 | In distribution | |
| MT-PT1418275R | In distribution | |
| MT-PT4605156L | In distribution | |
| MT-PS5714238 | In distribution | |
| MT-PT4108194R | In distribution | |
| MT-PS5712206 | In distribution | |
| MT-PS0606074 | In distribution | |
| MT-PT4405012L | In distribution | |
| MT-PT4710187R | In distribution | |
| MT-PT1420301R | In distribution | |
| MT-PS3703052 | In distribution | |
| MT-PT2003052L | In distribution | |
| MT-PT1904056R | In distribution | |
| MT-PS6312206 | In distribution | |
| MT-PS3712214 | In distribution | |
| MT-PS5402046 | In distribution | |
| MT-PT0109149L | In distribution | |
| MT-PS3713232 | In distribution | |
| MT-PT2912224 | In distribution | |
| MT-PT4404012R | In distribution | |
| MT-PT0704046 | In distribution | |
| MT-PT1708133L | In distribution | |
| MT-PT1618242 | In distribution | |
| MT-PT0105083R | In distribution | |
| MT-PT1704081R | In distribution | |
| MT-PT1205080L | In distribution | |
| MT-PS6112206 | In distribution | |
| MT-PT1408145R | In distribution | |
| MT-PT0307116L | In distribution | |
| MT-PT4206057 | In distribution | |
| MT-PS6305094 | In distribution | |
| MT-PT4813300L | In distribution | |
| MT-PT2614260 | In distribution | |
| MT-PT1006094R | In distribution | |
| MT-PT1609125 | In distribution | |
| MT-PT1219262R | In distribution | |
| MT-PT2916296 | In distribution | |
| MT-PS2514181 | In distribution | |
| MT-PT4607196R | In distribution | |
| MT-PT4203049L | In distribution | |
| MT-PS6008142 | In distribution | |
| MT-PT4611276R | In distribution | |
| MT-PT2007096L | In distribution |
Showing 250 of 300 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 |
|---|---|
| K171320 | 2018-03-08 |
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.