Plate, Fixation, Bone
Cortical Screw, Non-Lock., Self-tap., T6 Drive
22manufacturers in China registered for this device type
708catalogue 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) | K972323 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-24 (version 12) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 8 to 191 mm |
| Distribution end date | 2024-03-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 604024 | Length 24.0 mm | In distribution | |
| 605050 | Diameter: 2.7 Millimeter | In distribution | |
| 690020 | Length 150.0 mm | 10 | In distribution |
| 349630 | Length 30.0 mm | In distribution | |
| 341055 | Diameter: 6.5 Millimeter | In distribution | |
| 340656 | Length 56.0 mm | In distribution | |
| 601100 | Diameter: 4.5 Millimeter | In distribution | |
| 603032 | Diameter: 3.5 Millimeter | In distribution | |
| 54-25446S | Length 100.0 mm | In distribution | |
| 626674 | Length 47.0 mm | In distribution | |
| 343120 | Diameter: 6.5 Millimeter | In distribution | |
| 338045 | Diameter: 3.5 Millimeter | In distribution | |
| 602060 | Diameter: 6.5 Millimeter | In distribution | |
| 603016 | Diameter: 3.5 Millimeter | In distribution | |
| 340636 | Length 36.0 mm | In distribution | |
| 338020 | Length 20.0 mm | In distribution | |
| 603060 | Length 60.0 mm | In distribution | |
| 54-25440S | Length 145.0 mm | In distribution | |
| 603046 | Diameter: 3.5 Millimeter | In distribution | |
| 340632 | Length 32.0 mm | In distribution | |
| 345440 | Diameter: 4.0 Millimeter | In distribution | |
| 343030 | Length 30.0 mm | In distribution | |
| 604012 | Diameter: 4.0 Millimeter | In distribution | |
| 623004 | Length 37.0 mm | In distribution | |
| 623003 | Screw Holes: 3.0 Holes | In distribution | |
| 602085 | Length 85.0 mm | In distribution | |
| 345426 | Diameter: 4.0 Millimeter | In distribution | |
| 341115 | Diameter: 6.5 Millimeter | In distribution | |
| 602315 | Diameter: 6.5 Millimeter | In distribution | |
| 338055 | Length 55.0 mm | In distribution | |
| 349628 | Length 28.0 mm | In distribution | |
| 340626 | Diameter: 4.5 Millimeter | In distribution | |
| 345470 | Diameter: 4.0 Millimeter | In distribution | |
| 602290 | Diameter: 6.5 Millimeter | In distribution | |
| 345455 | Diameter: 4.0 Millimeter | In distribution | |
| 338675 | Diameter: 3.5 Millimeter | In distribution | |
| 602300 | Diameter: 6.5 Millimeter | In distribution | |
| 340634 | Diameter: 4.5 Millimeter | In distribution | |
| 603030 | Length 30.0 mm | In distribution | |
| 341095 | Length 95.0 mm | In distribution | |
| 343115 | Diameter: 6.5 Millimeter | In distribution | |
| 604018 | Diameter: 4.0 Millimeter | In distribution | |
| 603012 | Length 12.0 mm | In distribution | |
| 340648 | Diameter: 4.5 Millimeter | In distribution | |
| 342070 | Diameter: 6.5 Millimeter | In distribution | |
| 601018 | Diameter: 4.5 Millimeter | In distribution | |
| 605030 | Diameter: 2.7 Millimeter | In distribution | |
| 341150 | Length 150.0 mm | In distribution | |
| 345495 | Diameter: 4.0 Millimeter | In distribution | |
| 602265 | Diameter: 6.5 Millimeter | In distribution | |
| 54-25422S | Number of Screw Holes: 15.0 Holes | In distribution | |
| 338645 | Length 45.0 mm | In distribution | |
| 341125 | Diameter: 6.5 Millimeter | In distribution | |
| 605060S | Diameter: 2.7 Millimeter | In distribution | |
| 601042 | Diameter: 4.5 Millimeter | In distribution | |
| 338650 | Diameter: 3.5 Millimeter | In distribution | |
| 338644 | Diameter: 3.5 Millimeter | In distribution | |
| 605014S | Length 14.0 mm | In distribution | |
| 602530 | Length 130.0 mm | In distribution | |
| 338070 | Length 70.0 mm | In distribution | |
| 621208 | Length 104.0 mm | In distribution | |
| 343065 | Length 65.0 mm | In distribution | |
| 602065 | Diameter: 6.5 Millimeter | In distribution | |
| 340070 | Length 70.0 mm | In distribution | |
| 601016 | Length 16.0 mm | In distribution | |
| 604022 | Diameter: 4.0 Millimeter | In distribution | |
| 601115 | Diameter: 4.5 Millimeter | In distribution | |
| 345580 | Length 80.0 mm | In distribution | |
| 349618 | Length 18.0 mm | In distribution | |
| 340662 | Diameter: 4.5 Millimeter | In distribution | |
| 601080 | Diameter: 4.5 Millimeter | In distribution | |
| 340710 | Length 110.0 mm | In distribution | |
| 340740 | Diameter: 4.5 Millimeter | In distribution | |
| 604210 | Diameter: 4.0 Millimeter | In distribution | |
| 345535 | Diameter: 4.0 Millimeter | In distribution | |
| 626686S | Screw Holes: 16.0 Holes | In distribution | |
| 340618 | Diameter: 4.5 Millimeter | In distribution | |
| 342105 | Diameter: 6.5 Millimeter | In distribution | |
| 602330 | Diameter: 6.5 Millimeter | In distribution | |
| 338626 | Length 26.0 mm | In distribution | |
| 340655 | Length 55.0 mm | In distribution | |
| 340670 | Length 70.0 mm | In distribution | |
| 340658 | Diameter: 4.5 Millimeter | In distribution | |
| 343125 | Diameter: 6.5 Millimeter | In distribution | |
| 338715 | Length 115.0 mm | In distribution | |
| 604014 | Diameter: 4.0 Millimeter | In distribution | |
| 909-1006 | In distribution | ||
| 602120 | Diameter: 6.5 Millimeter | In distribution | |
| 603042 | Length 42.0 mm | In distribution | |
| 626675 | Screw Holes: 5.0 Holes | In distribution | |
| 602320 | Length 120.0 mm | In distribution | |
| 342125 | Length 125.0 mm | In distribution | |
| 341140 | Length 140.0 mm | In distribution | |
| 604036 | Diameter: 4.0 Millimeter | In distribution | |
| 345514 | Diameter: 4.0 Millimeter | In distribution | |
| 603014 | Diameter: 3.5 Millimeter | In distribution | |
| 338638 | Length 38.0 mm | In distribution | |
| 345434 | Length 34.0 mm | In distribution | |
| 340676 | Diameter: 4.5 Millimeter | In distribution | |
| 343110 | Length 110.0 mm | In distribution | |
| 603018 | Length 18.0 mm | In distribution | |
| 605010S | Length 10.0 mm | In distribution | |
| 602520 | Diameter: 6.5 Millimeter | In distribution | |
| 338705 | Diameter: 3.5 Millimeter | In distribution | |
| 603010 | Diameter: 3.5 Millimeter | In distribution | |
| 601065 | Diameter: 4.5 Millimeter | In distribution | |
| 604245 | Diameter: 4.0 Millimeter | In distribution | |
| 338050 | Length 50.0 mm | In distribution | |
| 601038 | Diameter: 4.5 Millimeter | In distribution | |
| 343055 | Length 55.0 mm | In distribution | |
| 341145 | Length 145.0 mm | In distribution | |
| 626682 | Screw Holes: 12.0 Holes | In distribution | |
| 340630 | Length 30.0 mm | In distribution | |
| 601014 | Length 14.0 mm | In distribution | |
| 343085 | Length 85.0 mm | In distribution | |
| 623008 | Length 73.0 mm | In distribution | |
| 54-25444S | Length 100.0 mm | In distribution | |
| 341050 | Diameter: 6.5 Millimeter | In distribution | |
| 340700 | Length 100.0 mm | In distribution | |
| 345555 | Diameter: 4.0 Millimeter | In distribution | |
| 338618 | Length 18.0 mm | In distribution | |
| 603024 | Diameter: 3.5 Millimeter | In distribution | |
| 340750 | Length 150.0 mm | In distribution | |
| 601095 | Diameter: 4.5 Millimeter | In distribution | |
| 340642 | Diameter: 4.5 Millimeter | In distribution | |
| 603044 | Diameter: 3.5 Millimeter | In distribution | |
| 602425 | Diameter: 6.5 Millimeter | In distribution | |
| 604016 | Diameter: 4.0 Millimeter | In distribution | |
| 623006 | Length 55.0 mm | In distribution | |
| 349620 | Diameter: 2.7 Millimeter | In distribution | |
| 626678S | Length 95.0 mm | In distribution | |
| 605032 | Length 32.0 mm | In distribution | |
| 349616 | Diameter: 2.7 Millimeter | In distribution | |
| 605038 | Length 38.0 mm | In distribution | |
| 342120 | Diameter: 6.5 Millimeter | In distribution | |
| 605034 | Diameter: 2.7 Millimeter | In distribution | |
| 603055 | Diameter: 3.5 Millimeter | In distribution | |
| 345422 | Length 22.0 mm | In distribution | |
| 338620 | Length 20.0 mm | In distribution | |
| 604040 | Length 40.0 mm | In distribution | |
| 340678 | Diameter: 4.5 Millimeter | In distribution | |
| 340026 | Diameter: 4.5 Millimeter | In distribution | |
| 604260 | Length 60.0 mm | In distribution | |
| 54-25428S | Length 100.0 mm | In distribution | |
| 343060 | Diameter: 6.5 Millimeter | In distribution | |
| 602450 | Length 50.0 mm | In distribution | |
| 626679S | Screw Holes: 9.0 Holes | In distribution | |
| 340660 | Length 60.0 mm | In distribution | |
| 345424 | Diameter: 4.0 Millimeter | In distribution | |
| 341030 | Diameter: 6.5 Millimeter | In distribution | |
| 601110 | Length 110.0 mm | In distribution | |
| 340616 | Diameter: 4.5 Millimeter | In distribution | |
| 602305 | Length 105.0 mm | In distribution | |
| 623007 | Screw Holes: 7.0 Holes | In distribution | |
| 601068 | Diameter: 4.5 Millimeter | In distribution | |
| 345435 | Length 35.0 mm | In distribution | |
| 340624 | Diameter: 4.5 Millimeter | In distribution | |
| 602295 | Length 95.0 mm | In distribution | |
| 602275 | Diameter: 6.5 Millimeter | In distribution | |
| 601064 | Diameter: 4.5 Millimeter | In distribution | |
| 602515 | Length 115.0 mm | In distribution | |
| 340028 | Length 28.0 mm | In distribution | |
| 340628 | Length 28.0 mm | In distribution | |
| 343100 | Diameter: 6.5 Millimeter | In distribution | |
| 601075 | Diameter: 4.5 Millimeter | In distribution | |
| 341085 | Length 85.0 mm | In distribution | |
| 101-1602 | Length 14.0 mm | In distribution | |
| 605024 | Diameter: 2.7 Millimeter | In distribution | |
| 604045 | Diameter: 4.0 Millimeter | In distribution | |
| 340730 | Diameter: 4.5 Millimeter | In distribution | |
| 338628 | Length 28.0 mm | In distribution | |
| 626673S | Screw Holes: 3.0 Holes | In distribution | |
| 338642 | Length 42.0 mm | In distribution | |
| 605020 | Length 20.0 mm | In distribution | |
| 602310 | Length 110.0 mm | In distribution | |
| 605012S | Diameter: 2.7 Millimeter | In distribution | |
| 601062 | Diameter: 4.5 Millimeter | In distribution | |
| 602525 | Length 125.0 mm | In distribution | |
| 338065 | Diameter: 3.5 Millimeter | In distribution | |
| 690030 | Diameter: 1.6 Millimeter | 10 | In distribution |
| 345416 | Length 16.0 mm | In distribution | |
| 349660 | Length 60.0 mm | In distribution | |
| 343070 | Diameter: 6.5 Millimeter | In distribution | |
| 345428 | Diameter: 4.0 Millimeter | In distribution | |
| 345522 | Diameter: 4.0 Millimeter | In distribution | |
| 345430 | Length 30.0 mm | In distribution | |
| 604236 | Diameter: 4.0 Millimeter | In distribution | |
| 601044 | Length 44.0 mm | In distribution | |
| 602080 | Length 80.0 mm | In distribution | |
| 602325 | Diameter: 6.5 Millimeter | In distribution | |
| 340048 | Diameter: 4.5 Millimeter | In distribution | |
| 601050 | Diameter: 4.5 Millimeter | In distribution | |
| 603065 | Length 65.0 mm | In distribution | |
| 349622 | Diameter: 2.7 Millimeter | In distribution | |
| 605055S | Length 55.0 mm | In distribution | |
| 343045 | Diameter: 6.5 Millimeter | In distribution | |
| 338695 | Length 95.0 mm | In distribution | |
| 602110 | Diameter: 6.5 Millimeter | In distribution | |
| 604030 | Length 30.0 mm | In distribution | |
| 604222 | Diameter: 4.0 Millimeter | In distribution | |
| 338720 | Diameter: 3.5 Millimeter | In distribution | |
| 605060 | Diameter: 2.7 Millimeter | In distribution | |
| 345570 | Length 70.0 mm | In distribution | |
| 102-4002 | In distribution | ||
| 338670 | Length 70.0 mm | In distribution | |
| 343080 | Diameter: 6.5 Millimeter | In distribution | |
| 602035 | Diameter: 6.5 Millimeter | In distribution | |
| 345536 | Diameter: 4.0 Millimeter | In distribution | |
| 602420 | Diameter: 6.5 Millimeter | In distribution | |
| 623009 | Screw Holes: 9.0 Holes | In distribution | |
| 342085 | Length 85.0 mm | In distribution | |
| 603045 | Diameter: 3.5 Millimeter | In distribution | |
| 338636 | Length 36.0 mm | In distribution | |
| 338616 | Diameter: 3.5 Millimeter | In distribution | |
| 602055 | Diameter: 6.5 Millimeter | In distribution | |
| 345545 | Diameter: 4.0 Millimeter | In distribution | |
| 342095 | Length 95.0 mm | In distribution | |
| 604226 | Diameter: 4.0 Millimeter | In distribution | |
| 338028 | Length 28.0 mm | In distribution | |
| 604224 | Length 24.0 mm | In distribution | |
| 603022 | Length 22.0 mm | In distribution | |
| 101-1603 | Diameter: 2.7 Millimeter | In distribution | |
| 343025 | Diameter: 6.5 Millimeter | In distribution | |
| 601030 | Diameter: 4.5 Millimeter | In distribution | |
| 340664 | Diameter: 4.5 Millimeter | In distribution | |
| 345560 | Diameter: 4.0 Millimeter | In distribution | |
| 605036 | Length 36.0 mm | In distribution | |
| 345565 | Length 65.0 mm | In distribution | |
| 343105 | Diameter: 6.5 Millimeter | In distribution | |
| 601028 | Diameter: 4.5 Millimeter | In distribution | |
| 338012 | Diameter: 3.5 Millimeter | In distribution | |
| 602430 | Diameter: 6.5 Millimeter | In distribution | |
| 619905S | In distribution | ||
| 340652 | Length 52.0 mm | In distribution | |
| 101-1600 | Length 10.0 mm | In distribution | |
| 54-25436S | Number of Screw Holes: 15.0 Holes | In distribution | |
| 345450 | Diameter: 4.0 Millimeter | In distribution | |
| 601070 | Length 70.0 mm | In distribution | |
| 343090 | Diameter: 6.5 Millimeter | In distribution | |
| 345438 | Length 38.0 mm | In distribution | |
| 349655 | Diameter: 2.7 Millimeter | In distribution | |
| 602050 | Diameter: 6.5 Millimeter | In distribution | |
| 341045 | Diameter: 6.5 Millimeter | In distribution | |
| 340650 | Diameter: 4.5 Millimeter | In distribution | |
| 601052 | Diameter: 4.5 Millimeter | In distribution | |
| 342055 | Diameter: 6.5 Millimeter | In distribution | |
| 342090 | Diameter: 6.5 Millimeter | In distribution | |
| 345475 | Length 75.0 mm | In distribution | |
| 602470 | Diameter: 6.5 Millimeter | In distribution | |
| 338655 | Diameter: 3.5 Millimeter | 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 |
|---|---|
| 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.