Accord
Accord Standard 265MM 11 Cable Trochanteric Grip
5manufacturers in China registered for this device type
15catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this 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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K031162 |
| Record published | 2015-08-30 |
| Record revised | 2025-11-20 (version 12) |
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, manufacturing date |
| Sizes | Outer diameter 2 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71340001 | In distribution | |
| 71340020 | In distribution | |
| 71340008 | Outer Diameter 2 mm | In distribution |
| 71340006 | SMALL 255MM 11 CABLE: SMALL 255MM 11 CABLE Millimeter | In distribution |
| 71340002 | In distribution | |
| 71340004 | SMALL 115MM 5 CABLE: SMALL 115MM 5 CABLE Millimeter | In distribution |
| 71340010 | STANDARD 85MM 3 CABLE: STANDARD 85MM 3 CABLE Millimeter | In distribution |
| 71340012 | STANDARD 195MM 8 CABLE: STANDARD 195MM 8 CABLE Millimeter | In distribution |
| 71340007 | Outer Diameter 2 mm | In distribution |
| 71340013 | STANDARD 265MM 11 CABLE: STANDARD 265MM 11 CABLE Millimeter | In distribution |
| 71340011 | STANDARD 125MM 5 CABLE: STANDARD 125MM 5 CABLE Millimeter | In distribution |
| 71340015 | In distribution | |
| 71340014 | In distribution | |
| 71340005 | SMALL 185MM 8 CABLE: SMALL 185MM 8 CABLE Millimeter | In distribution |
| 71340003 | SMALL 75MM 3 CABLE: SMALL 75MM 3 CABLE Millimeter | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233949 | 2024-03-13 |
| K043252 | 2005-01-14 |
| K031162 | 2003-05-01 |
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 |
|---|---|---|---|---|---|
| 2010-06-28 | Not classified | Process control | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility. | 34 units | 2012-01-23 |
| 2010-06-28 | Not classified | Process control | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility. | 1 unit | 2012-01-23 |
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.