Poly Suture Button
2 catalogue numbers from 904219, listed by Biomet Sports Medicine, United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Biomet Sports Medicine, United States |
|---|---|
| FDA product code | KGS |
| Device type | Retention Device, Suture |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4930 |
| 510(k) | K813581 |
| Record published | 2015-10-24 |
| Record revised | 2025-06-25 (version 5) |
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 |
|---|---|---|
| 904219 | 19 MM | In distribution |
| 904215 | 15 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 20 |
| Xtendobutton | Smith & Nephew, Inc. | 7 |
| Dynamic Tissue Systems™ | Southmedic, Inc. | 4 |
| Retention Device, Suture | Smith & Nephew, Inc. | 2 |
| Vive | Vive Health LLC | 2 |
| Perchik | AngioDynamics, Inc. | 2 |
| FlowStasis | Inari Medical, Inc. | 2 |
| Stent Buttons | Boston Medical Products, Inc. | 2 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Slip-Not® | Merit Medical Systems, Inc. | 2 |
| StarGuard Suture Retention Plates – 9″ | Preservation Solutions, Inc. | 1 |
Showing 12 of 29. All products under Retention Device, Suture
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.