5MS™
5MS™ JONES FRACTURE SCREW, Ø5.5X50.0 mm
22manufacturers in China registered for this device type
55catalogue numbers in this listing
16510(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 | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K170518 |
| Record published | 2017-08-14 |
| Record revised | 2025-11-20 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P64 ST728 | In distribution | |
| P64 ST708 | In distribution | |
| P60 ST550 | In distribution | |
| P62 ST413 | In distribution | |
| P64 ST428 | In distribution | |
| P62 ST720 | In distribution | |
| P60 ST450 | In distribution | |
| P62 ST428 | In distribution | |
| P60 ST657 | In distribution | |
| P60 ST665 | In distribution | |
| P62 ST724 | In distribution | |
| P60 ST455 | In distribution | |
| P60 ST570 | In distribution | |
| P60 ST440 | In distribution | |
| P64 ST420 | In distribution | |
| P60 ST555 | In distribution | |
| P64 ST724 | In distribution | |
| P60 ST460 | In distribution | |
| P64 ST710 | In distribution | |
| P60 ST043 | In distribution | |
| P62 ST424 | In distribution | |
| P64 ST412 | In distribution | |
| P60 ST642 | In distribution | |
| P62 ST420 | In distribution | |
| P64 ST408 | In distribution | |
| P64 ST414 | In distribution | |
| P60 ST652 | In distribution | |
| P62 ST710 | In distribution | |
| P60 ST465 | In distribution | |
| P62 ST728 | In distribution | |
| P64 ST424 | In distribution | |
| P62 ST712 | In distribution | |
| P64 ST416 | In distribution | |
| P60 ST545 | In distribution | |
| P62 ST415 | In distribution | |
| P64 ST410 | In distribution | |
| P60 ST560 | In distribution | |
| P62 ST411 | In distribution | |
| P60 ST021 | In distribution | |
| P60 ST011 | In distribution | |
| P60 ST033 | In distribution | |
| P62 ST716 | In distribution | |
| P62 ST708 | In distribution | |
| P64 ST714 | In distribution | |
| P64 ST716 | In distribution | |
| P60 ST445 | In distribution | |
| P64 ST712 | In distribution | |
| P60 ST031 | In distribution | |
| P60 ST051 | In distribution | |
| P60 ST540 | In distribution | |
| P60 ST647 | In distribution | |
| P62 ST409 | In distribution | |
| P62 ST714 | In distribution | |
| P64 ST720 | In distribution | |
| P60 ST041 | In distribution |
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 |
|---|---|
| K241387 | 2024-08-13 |
| K233089 | 2024-05-24 |
| K213698 | 2022-05-27 |
| K213069 | 2021-12-13 |
| K212487 | 2021-11-18 |
| K210060 | 2021-03-12 |
| K201149 | 2020-07-15 |
| K200762 | 2020-04-23 |
| K193543 | 2020-01-17 |
| K190385 | 2019-08-08 |
| K191535 | 2019-07-29 |
| K182402 | 2018-09-27 |
| K181113 | 2018-06-15 |
| K172300 | 2017-11-27 |
| K170518 | 2017-07-14 |
| K163293 | 2017-05-05 |
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.