Xtendobutton
XTENDOBUTTON Oval Medium 11 mm x 18 mm 7.5 mm peg
3manufacturers in China registered for this device type
7catalogue numbers in this listing
1510(k) clearance
1recall
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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | KGS |
| Device type | Retention Device, Suture |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4930 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-05-09 |
| Record revised | 2023-09-07 (version 6) |
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 |
|---|---|---|
| 71935606 | In distribution | |
| 71935605 | In distribution | |
| 71935604 | In distribution | |
| 72200134 | In distribution | |
| 71935603 | In distribution | |
| 71935601 | In distribution | |
| 71935602 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 20 |
| 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 |
| Poly Suture Button | Biomet Sports Medicine | 2 |
| StarGuard Suture Retention Plates – 9″ | Preservation Solutions, Inc. | 1 |
Showing 12 of 29. All products under Retention Device, Suture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020480 | 2002-03-12 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-03-24 | Not classified | Other | The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor. | 1800 units | 2007-12-12 |
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.