Endophix
71 catalogue numbers from MS-2167-60, listed by Suzhou Endophix Co., Ltd., China, under Fastener, Fixation, Nondegradable, Soft Tissue. 7 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Suzhou Endophix Co., Ltd., China |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K232941 |
| Record published | 2026-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS-2167-60 | In distribution | |
| MS-1555PSK | In distribution | |
| MS-1255 | In distribution | |
| MS-1135 | In distribution | |
| MS-2167-35 | In distribution | |
| MS-1245N | In distribution | |
| MS-1537PLK1 | In distribution | |
| MS-1525PTK | In distribution | |
| MS-1530PT | In distribution | |
| MS-1537PLK2 | In distribution | |
| MS-2168-U | In distribution | |
| MS-2166-25 | In distribution | |
| MS-1565PS | In distribution | |
| MS-1545PTK | In distribution | |
| MS-2167-15 | In distribution | |
| MS-1520PT | In distribution | |
| MS-2161 | In distribution | |
| MS-2168-S | In distribution | |
| MS-2167-25 | In distribution | |
| MS-2166-60 | In distribution | |
| MS-1535PTK | In distribution | |
| MS-2166-15 | In distribution | |
| MS-1128-1 | In distribution | |
| MS-1255N | In distribution | |
| MS-1128 | In distribution | |
| MS-1165N | In distribution | |
| MS-1545PLK | In distribution | |
| MS-2162 | In distribution | |
| MS-1245 | In distribution | |
| MS-2165 | In distribution | |
| MS-2166-30 | In distribution | |
| MS-2167-40 | In distribution | |
| MS-2025PS-6 | In distribution | |
| MS-2169 | In distribution | |
| MS-2025PS-10 | In distribution | |
| MS-1545PS | In distribution | |
| MS-2166-50 | In distribution | |
| MS-2025PS-8 | In distribution | |
| MS-1555PLK | In distribution | |
| MS-1120 | In distribution | |
| MS-2025PS-11 | In distribution | |
| MS-2167-55 | In distribution | |
| MS-2166-40 | In distribution | |
| MS-1555PS | In distribution | |
| MS-1135N | In distribution | |
| MS-2167-30 | In distribution | |
| MS-1150 | In distribution | |
| MS-1165 | In distribution | |
| MS-1547PSK | In distribution | |
| MS-2166-35 | In distribution | |
| MS-2164 | In distribution | |
| MS-2166-55 | In distribution | |
| MS-2167-50 | In distribution | |
| MS-1128N | In distribution | |
| MS-2167-45 | In distribution | |
| MS-2025PS-7 | In distribution | |
| MS-2025PS-9 | In distribution | |
| MS-2160 | In distribution | |
| MS-1535PSK | In distribution | |
| MS-1524PT | In distribution | |
| MS-2168-L | In distribution | |
| MS-2166-45 | In distribution | |
| MS-1150N | In distribution | |
| MS-2167-20 | In distribution | |
| MS-2166-20 | In distribution | |
| MS-1529PTK | In distribution | |
| MS-1265N | In distribution | |
| MS-1128-1N | In distribution | |
| MS-1120N | In distribution | |
| MS-2163 | In distribution | |
| MS-1265 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
| Twinfix | Smith & Nephew, Inc. | 45 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232941 | 2024-05-03 |
| K232725 | 2023-11-02 |
| K231002 | 2023-06-07 |
| K230874 | 2023-05-23 |
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.