VariAx
Polyaxial Locking Plate Medial Column Fusion, Right, Short
22manufacturers in China registered for this device type
1,934catalogue numbers in this listing
25510(k) clearances naming this product code
1recall
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170771 |
| Record published | 2015-09-24 |
| Record revised | 2025-04-14 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 2.2 to 876 mm |
| Distribution end date | 2022-11-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 54-25295S | Number of Screw Holes: 14.0 Holes | In distribution | |
| 58-23015E | Length 15.0 mm | In distribution | |
| 57-10360S | Number of Screw Holes: 7.0 Holes | In distribution | |
| 53-17013 | Diameter: 1.7 Millimeter | 5 | In distribution |
| 57-15340S | Number of Screw Holes: 6.0 Holes | In distribution | |
| 626973S | Number of Screw Holes: 3.0 Holes | In distribution | |
| 629514 | Number of Screw Holes: 14.0 Holes | In distribution | |
| 629688 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 625121S | Side: LEFT | In distribution | |
| 40-10116 | Number of Screw Holes: 12.0 Holes | In distribution | |
| 58-19005E | Length 5.0 mm | In distribution | |
| 625204 | In distribution | ||
| 58-12016E | Length 16.0 mm | In distribution | |
| 625241S | Side: LEFT | In distribution | |
| 58-23022 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 629728 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 53-23006S | Diameter: 2.3 Millimeter | In distribution | |
| 40-15071 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 629543S | Screw Holes: 3.0 Holes | In distribution | |
| 54-25442 | Number of Screw Holes: 11.0 Holes | In distribution | |
| 628068S | Screw Holes: 8.0 Holes | In distribution | |
| 706617 | In distribution | ||
| 629328 | Length 151.0 mm | In distribution | |
| 629290S | Length 167.0 mm | In distribution | |
| 53-17008S | Length 8.0 mm | In distribution | |
| 40-10102S | Number of Screw Holes: 12.0 Holes | In distribution | |
| 54-25403 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 657418S | Diameter: 3.5 Millimeter | In distribution | |
| 53-23010 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 58-23008S | Diameter: 2.3 Millimeter | In distribution | |
| 57-15301 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 628010S | Screw Holes: 10.0 Holes | In distribution | |
| 40-15031S | Number of Screw Holes: 6.0 Holes | In distribution | |
| 57-10379 | Number of Screw Holes: 9.0 Holes | In distribution | |
| 629791 | Length 81.0 mm | In distribution | |
| 57-15321 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 628030 | Screw Holes: 10.0 Holes | In distribution | |
| 629690 | Length 69.0 mm | In distribution | |
| 40-20810 | Length 132.0 mm | In distribution | |
| 706603 | In distribution | ||
| 58-23008 | Length 8.0 mm | 5 | In distribution |
| 629648S | Length 54.0 mm | In distribution | |
| 626984 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 58-17016S | Diameter: 1.7 Millimeter | In distribution | |
| 628539S | Number of Screw Holes: 9.0 Holes | In distribution | |
| 58-12008 | Length 8.0 mm | 5 | In distribution |
| 54-25450 | Number of Screw Holes: 5.0 Holes | In distribution | |
| 40-20816S | Screw Holes: 16.0 Holes | In distribution | |
| 53-23011S | Length 11.0 mm | In distribution | |
| 629714S | Number of Screw Holes: 14.0 Holes | In distribution | |
| 54-25677 | Number of Screw Holes: 14.0 Holes | In distribution | |
| 629730 | Length 79.0 mm | In distribution | |
| 53-23024 | Length 24.0 mm | 5 | In distribution |
| 40-27900S | Thickness: 0.5 Millimeter | In distribution | |
| 58-23014E | Length 14.0 mm | In distribution | |
| 629383S | Screw Holes: 3.0 Holes | In distribution | |
| 629547 | Length 91.0 mm | In distribution | |
| 57-15397S | Bended Plate: 2×2+2 Holes | In distribution | |
| 52-27720S | Length 20.0 mm | In distribution | |
| 40-20808 | Length 108.0 mm | In distribution | |
| 629348S | Screw Holes: 8.0 Holes | In distribution | |
| 53-23011 | Length 11.0 mm | 5 | In distribution |
| 58-12005 | Length 5.0 mm | 5 | In distribution |
| 629310S | Length 175.0 mm | In distribution | |
| 614536 | Diameter: 2.7 Millimeter | In distribution | |
| 629670 | Number of Screw Holes: 10.0 Holes | In distribution | |
| 629388S | Length 139.0 mm | In distribution | |
| 629283 | Length 72.0 mm | In distribution | |
| 58-12006E | Diameter: 1.2 Millimeter | In distribution | |
| 629690S | Number of Screw Holes: 10.0 Holes | In distribution | |
| 58-12007E | Diameter: 1.2 Millimeter | In distribution | |
| 56-01810 | Number of Screw Holes: 7.0 Holes | In distribution | |
| 940274 | In distribution | ||
| 53-23009 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 629684 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 629222 | Screw Holes: 2.0 Holes | In distribution | |
| 622100 | In distribution | ||
| 626812S | In distribution | ||
| 625224S | In distribution | ||
| 54-25375 | Number of Screw Holes: 12.0 Holes | In distribution | |
| 625120 | Length 43.0 mm | In distribution | |
| 53-23024E | Length 24.0 mm | In distribution | |
| 58-17010S | Diameter: 1.7 Millimeter | In distribution | |
| 625106S | Length 172.0 mm | In distribution | |
| 54-25293S | Number of Screw Holes: 11.0 Holes | In distribution | |
| 58-12018S | Length 18.0 mm | In distribution | |
| 40-10106S | Number of Screw Holes: 16.0 Holes | In distribution | |
| 58-25012 | Length 12.0 mm | 5 | In distribution |
| 657446S | Length 46.0 mm | In distribution | |
| 626975S | Number of Screw Holes: 5.0 Holes | In distribution | |
| 940281 | In distribution | ||
| 40-15072 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 628066 | Screw Holes: 6.0 Holes | In distribution | |
| 626982S | Number of Screw Holes: 2.0 Holes | In distribution | |
| 58-12005S | Diameter: 1.2 Millimeter | In distribution | |
| 625211S | Length 47.0 mm | In distribution | |
| 57-15360S | Number of Screw Holes: 7.0 Holes | In distribution | |
| 940215 | In distribution | ||
| 54-25438 | Number of Screw Holes: 15.0 Holes | In distribution | |
| 626752S | In distribution | ||
| 625202S | In distribution | ||
| 657430S | Diameter: 3.5 Millimeter | In distribution | |
| 628557S | Number of Screw Holes: 7.0 Holes | In distribution | |
| 628028 | Screw Holes: 8.0 Holes | In distribution | |
| 626967 | Number of Screw Holes: 7.0 Holes | In distribution | |
| 629224 | Length 109.0 mm | In distribution | |
| 625104 | Length 58.0 mm | In distribution | |
| 40-15021S | Number of Screw Holes: 4.0 Holes | In distribution | |
| 40-15061 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 625251 | Length 53.0 mm | In distribution | |
| 629202 | Length 72.0 mm | In distribution | |
| 629263S | Screw Holes: 3.0 Holes | In distribution | |
| 629248S | Length 150.0 mm | In distribution | |
| 626772S | In distribution | ||
| 628148S | Screw Holes: 8.0 Holes | In distribution | |
| 626882S | In distribution | ||
| 629708S | Number of Screw Holes: 8.0 Holes | In distribution | |
| 53-17011 | Diameter: 1.7 Millimeter | 5 | In distribution |
| 625098S | Side: RIGHT | In distribution | |
| 625230S | Length 49.0 mm | In distribution | |
| 58-23020S | Length 20.0 mm | In distribution | |
| 40-10114 | Number of Screw Holes: 12.0 Holes | In distribution | |
| 58-19010 | Length 10.0 mm | 5 | In distribution |
| 625106 | Length 172.0 mm | In distribution | |
| 625261S | Side: LEFT | In distribution | |
| 629754S | Number of Screw Holes: 14.0 Holes | In distribution | |
| 703948 | In distribution | ||
| 629748S | Number of Screw Holes: 8.0 Holes | In distribution | |
| 657420S | Diameter: 3.5 Millimeter | In distribution | |
| 614650 | Diameter: 3.5 Millimeter | In distribution | |
| 58-19012S | Diameter: 1.9 Millimeter | In distribution | |
| 625204S | In distribution | ||
| 626983 | Number of Screw Holes: 3.0 Holes | In distribution | |
| 57-10392 | 3D Plates: 4×2 Holes | In distribution | |
| 57-10380S | Number of Screw Holes: 5.0 Holes | In distribution | |
| 940354 | In distribution | ||
| 626992S | Number of Screw Holes: 2.0 Holes | In distribution | |
| 629700 | Length 135.0 mm | In distribution | |
| 52-27716S | Diameter: 2.7 Millimeter | In distribution | |
| 629506 | Screw Holes: 6.0 Holes | In distribution | |
| 628203S | Screw Holes: 3.0 Holes | In distribution | |
| 626977 | Number of Screw Holes: 7.0 Holes | In distribution | |
| 54-25374S | Number of Screw Holes: 9.0 Holes | In distribution | |
| 614530 | Diameter: 2.7 Millimeter | In distribution | |
| 628308 | Screw Holes: 8.0 Holes | In distribution | |
| 625093 | Side: LEFT | In distribution | |
| 625104S | Length 58.0 mm | In distribution | |
| 58-23022S | Length 22.0 mm | In distribution | |
| 58-17005S | Length 5.0 mm | In distribution | |
| 657438S | Diameter: 3.5 Millimeter | In distribution | |
| 626880 | In distribution | ||
| 54-25293 | Number of Screw Holes: 11.0 Holes | In distribution | |
| 657360S | Diameter: 3.5 Millimeter | In distribution | |
| 40-15092S | Number of Screw Holes: 5.0 Holes | In distribution | |
| 58-17016 | Length 16.0 mm | 5 | In distribution |
| 629512S | Length 150.0 mm | In distribution | |
| 657338S | Length 38.0 mm | In distribution | |
| 614718 | Length 18.0 mm | In distribution | |
| 54-25296S | Number of Screw Holes: 14.0 Holes | In distribution | |
| 57-10310S | Number of Screw Holes: 10.0 Holes | In distribution | |
| 629773 | Length 62.0 mm | In distribution | |
| 614850 | Diameter: 3.5 Millimeter | In distribution | |
| 940336 | In distribution | ||
| 58-23026 | Length 26.0 mm | 5 | In distribution |
| 53-17011E | Length 11.0 mm | In distribution | |
| 626761 | In distribution | ||
| 58-23020 | Length 20.0 mm | 5 | In distribution |
| 58-23016E | Length 16.0 mm | In distribution | |
| 657308S | Length 8.0 mm | In distribution | |
| 626996S | Number of Screw Holes: 6.0 Holes | In distribution | |
| 58-12006 | Diameter: 1.2 Millimeter | 5 | In distribution |
| 53-17014S | Diameter: 1.7 Millimeter | In distribution | |
| 57-10321 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 940342 | In distribution | ||
| 54-25402 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 56-01910 | Number of Screw Holes: 7.0 Holes | In distribution | |
| 58-17016E | Diameter: 1.7 Millimeter | In distribution | |
| 625213 | Length 54.0 mm | In distribution | |
| 625214S | In distribution | ||
| 628204 | Screw Holes: 4.0 Holes | In distribution | |
| 629664S | Number of Screw Holes: 4.0 Holes | In distribution | |
| 54-25444 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 54-25402S | Number of Screw Holes: 4.0 Holes | In distribution | |
| 629564 | Length 175.0 mm | In distribution | |
| 625242 | In distribution | ||
| 53-17018S | Length 18.0 mm | In distribution | |
| 629790 | Number of Screw Holes: 10.0 Holes | In distribution | |
| 629628S | Number of Screw Holes: 8.0 Holes | In distribution | |
| 614712 | Length 12.0 mm | In distribution | |
| 57-15390S | 3D Plates: 2×2 Holes | In distribution | |
| 614614 | Diameter: 3.5 Millimeter | In distribution | |
| 657416S | Diameter: 3.5 Millimeter | In distribution | |
| 626962S | Number of Screw Holes: 2.0 Holes | In distribution | |
| 625092 | Side: RIGHT | In distribution | |
| 940090 | In distribution | ||
| 53-23009S | Length 9.0 mm | In distribution | |
| 614565 | Length 65.0 mm | In distribution | |
| 629668 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 622106 | In distribution | ||
| 628227S | Screw Holes: 7.0 Holes | In distribution | |
| 54-25405S | Number of Screw Holes: 6.0 Holes | In distribution | |
| 625090S | Length 47.0 mm | In distribution | |
| 625251S | Length 53.0 mm | In distribution | |
| 54-25684S | Number of Screw Holes: 11.0 Holes | In distribution | |
| 58-25010S | Length 10.0 mm | In distribution | |
| 56-01610 | Number of Screw Holes: 7.0 Holes | In distribution | |
| 657348S | Length 48.0 mm | In distribution | |
| 54-25683 | Number of Screw Holes: 10.0 Holes | In distribution | |
| 626881S | In distribution | ||
| 40-20803 | Length 40.5 mm | In distribution | |
| 58-14003 | Diameter: 1.4 Millimeter | 5 | In distribution |
| 57-15324 | Number of Screw Holes: 5.0 Holes | In distribution | |
| 53-23008S | Diameter: 2.3 Millimeter | In distribution | |
| 58-12016S | Diameter: 1.2 Millimeter | In distribution | |
| 53-23020E | Length 20.0 mm | In distribution | |
| 629610S | Length 54.0 mm | In distribution | |
| 629222S | Length 72.0 mm | In distribution | |
| 53-23011E | Length 11.0 mm | In distribution | |
| 40-15011S | Number of Screw Holes: 4.0 Holes | In distribution | |
| 53-23022 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 629606 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 629756 | Length 142.0 mm | In distribution | |
| 614824 | Length 24.0 mm | In distribution | |
| 614818 | Diameter: 3.5 Millimeter | In distribution | |
| 625231S | Side: LEFT | In distribution | |
| 703853 | Screw Holes: 7.0 Holes | In distribution | |
| 53-17006E | Diameter: 1.7 Millimeter | In distribution | |
| 629344S | Screw Holes: 4.0 Holes | In distribution | |
| 626753 | In distribution | ||
| 53-17014E | Diameter: 1.7 Millimeter | In distribution | |
| 629610 | Length 54.0 mm | In distribution | |
| 53-17016S | Length 16.0 mm | In distribution | |
| 628048S | Screw Holes: 8.0 Holes | In distribution | |
| 614514 | Length 14.0 mm | In distribution | |
| 940276 | In distribution | ||
| 629784 | Length 47.0 mm | In distribution | |
| 629250S | Length 173.0 mm | In distribution | |
| 625212 | Length 54.0 mm | In distribution | |
| 629248 | Length 150.0 mm | In distribution | |
| 58-23018E | Length 18.0 mm | In distribution | |
| 40-15032 | Number of Screw Holes: 5.0 Holes | In distribution | |
| 628559S | Number of Screw Holes: 9.0 Holes | In distribution | |
| 614512 | Length 12.0 mm | In distribution | |
| 940361 | In distribution | ||
| 58-25008 | Diameter: 2.5 Millimeter | 5 | In distribution |
| 657444S | Length 44.0 mm | In distribution | |
| 629750 | Length 90.0 mm | In distribution | |
| 629508 | Length 102.0 mm | In distribution | |
| 629716S | Length 126.0 mm | In distribution | |
| 53-17020E | Length 20.0 mm | 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 |
| 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 |
| LCP | Synthes Gmbh | 1,295 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242445 | 2024-10-06 |
| K233919 | 2024-03-25 |
| K231257 | 2023-08-18 |
| K231262 | 2023-08-18 |
| K222381 | 2023-04-27 |
| K223772 | 2023-04-07 |
| K221346 | 2022-07-08 |
| K212581 | 2022-01-19 |
| K200398 | 2020-06-05 |
| K192675 | 2019-11-22 |
| K191412 | 2019-08-23 |
| K183172 | 2019-03-05 |
| K181091 | 2018-10-11 |
| K172148 | 2018-03-19 |
| K172350 | 2017-12-15 |
| K170727 | 2017-06-22 |
| K170771 | 2017-05-08 |
| K162841 | 2017-02-21 |
| K162439 | 2017-02-03 |
| K153379 | 2016-05-26 |
| K151769 | 2015-10-27 |
| K151879 | 2015-08-06 |
| K113109 | 2011-12-23 |
| K112926 | 2011-12-19 |
| K110476 | 2011-03-18 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-12-05 | Class II | Under Investigation by firm | Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. | 433 (289 units U.S. / 144 units OUS) | 2020-10-09 |
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.