Cable-Ready®
14 catalogue numbers from 2232-02-28, listed by Zimmer, Inc., United States, under Cerclage, Fixation. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
14catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K151907 |
| Record published | 2015-09-17 |
| Record revised | 2025-11-20 (version 8) |
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 |
| Sizes | Length 65 to 889 mm; length 22 to 36 in; width 22.1 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2232-02-28 | 1.8 mm Diameter Cable | In distribution |
| 2232-50-18 | Pin: 4 mm Diameter, Cable: 1.3 mm Diameter | In distribution |
| 2232-05-18 | 1.8 mm Diameter | In distribution |
| 2232-03-18 | Length 24 in | In distribution |
| 2232-50-21 | Pin: 4 mm Diameter, Cable: 1.3 mm Diameter | In distribution |
| 2232-01-18 | 1.8 mm Diameter Cable | In distribution |
| 2232-03-03 | Length 305 mm | In distribution |
| 2232-02-01 | Width 22.1 mm | In distribution |
| 2232-50-20 | Pin: 4 mm Diameter, Cable: 1.3 mm Diameter | In distribution |
| 2232-11-13 | 1.3 mm Diameter Cable | In distribution |
| 2232-03-02 | Length 246 mm | In distribution |
| 2232-50-19 | Length 483 mm | In distribution |
| 2232-01-28 | 1.8 mm Diameter Cable | In distribution |
| 2232-21-13 | 1.3 mm Diameter Cable | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cerclage, Fixation | Synthes Gmbh | 102 |
| Optilink | Synthes Gmbh | 61 |
| 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151848 | 2016-01-15 |
| K150889 | 2015-07-01 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
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.