Optilink
5.0MM VAL Screw/Optilink(TM) SLF-TPNG/STRDRV/110MM-STERILE
5manufacturers in China registered for this device type
61catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (2), Jiangsu (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 |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K162124 |
| Record published | 2019-10-21 |
| Record revised | 2025-02-06 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42.231.675 | In distribution | |
| 42.231.635 | In distribution | |
| 42.231.700S | In distribution | |
| 42.231.285 | In distribution | |
| 42.231.240 | In distribution | |
| 42.231.236 | In distribution | |
| 42.231.248 | In distribution | |
| 42.231.625 | In distribution | |
| 42.231.290 | In distribution | |
| 42.231.255 | In distribution | |
| 42.231.230 | In distribution | |
| 42.231.310S | In distribution | |
| 42.231.224 | In distribution | |
| 42.231.620 | In distribution | |
| 42.231.300S | In distribution | |
| 42.231.685 | In distribution | |
| 42.231.630 | In distribution | |
| 42.231.214 | In distribution | |
| 42.231.244 | In distribution | |
| 42.231.218 | In distribution | |
| 42.231.226 | In distribution | |
| 42.231.014S | In distribution | |
| 42.231.265 | In distribution | |
| 42.231.232 | In distribution | |
| 42.231.295S | In distribution | |
| 42.231.012 | In distribution | |
| 42.231.705S | In distribution | |
| 42.231.216 | In distribution | |
| 42.231.222 | In distribution | |
| 42.231.670 | In distribution | |
| 42.231.234 | In distribution | |
| 42.231.018S | In distribution | |
| 42.231.640 | In distribution | |
| 42.231.018 | In distribution | |
| 42.231.016S | In distribution | |
| 42.231.275 | In distribution | |
| 42.231.010 | In distribution | |
| 42.231.016 | In distribution | |
| 42.231.270 | In distribution | |
| 42.231.690 | In distribution | |
| 42.231.665 | In distribution | |
| 42.231.660 | In distribution | |
| 42.231.650 | In distribution | |
| 42.231.645 | In distribution | |
| 42.231.250 | In distribution | |
| 42.231.305S | In distribution | |
| 42.231.238 | In distribution | |
| 42.231.010S | In distribution | |
| 42.231.695S | In distribution | |
| 42.231.228 | In distribution | |
| 42.231.246 | In distribution | |
| 42.231.655 | In distribution | |
| 42.231.710S | In distribution | |
| 42.231.242 | In distribution | |
| 42.231.008S | In distribution | |
| 42.231.220 | In distribution | |
| 42.231.012S | In distribution | |
| 42.231.680 | In distribution | |
| 42.231.260 | In distribution | |
| 42.231.280 | In distribution | |
| 42.231.014 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cerclage, Fixation | Synthes Gmbh | 102 |
| Songer® Spinal Cable System | Pioneer Surgical Technology, Inc. | 60 |
| DePuy Songer Spinal Cable System | Pioneer Surgical Technology, Inc. | 36 |
| Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 34 |
| Dall-Miles | Howmedica Osteonics Corp | 22 |
| Sternal Cable System | Pioneer Surgical Technology, Inc. | 20 |
| Sternal Cable System | A & E Medical Corporation | 19 |
| Compression Screw System | Biomet Orthopedics | 18 |
| Accord | Smith & Nephew, Inc. | 15 |
| Cable-Ready® | Zimmer, Inc. | 14 |
| Arthrex® | Arthrex, Inc. | 10 |
| Stitch Cerclage – Suture Tapes | GM DOS Reis Industria E Comercio Ltda | 10 |
Showing 12 of 56. All products under Cerclage, Fixation
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.