Compression Screw System
18 catalogue numbers from 18-235132, listed by Biomet Orthopedics, United States, under Cerclage, Fixation. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
18catalogue 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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| 510(k) | K982545 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-235132 | 4.5MM Ø 32MM LENGTH | In distribution |
| 18-235144 | 4.5MM Ø 44MM LENGTH | In distribution |
| 18-235164 | 4.5MM Ø 64MM LENGTH | In distribution |
| 18-235156 | 4.5MM Ø 56MM LENGTH | In distribution |
| 18-235140 | 4.5MM Ø 40MM LENGTH | In distribution |
| 18-235152 | 4.5MM Ø 52MM LENGTH | In distribution |
| 18-235170 | 4.5MM Ø 70MM LENGTH | In distribution |
| 18-235150 | 4.5MM Ø 50MM LENGTH | In distribution |
| 18-235120 | 4.5MM Ø 20MM LENGTH | In distribution |
| 18-235136 | 4.5MM Ø 36MM LENGTH | In distribution |
| 18-235130 | 4.5MM Ø 30MM LENGTH | In distribution |
| 18-235134 | 4.5MM Ø 34MM LENGTH | In distribution |
| 18-235116 | 4.5MM Ø 16MM LENGTH | In distribution |
| 18-235124 | 4.5MM Ø 24MM LENGTH | In distribution |
| 18-235154 | 4.5MM Ø 54MM LENGTH | In distribution |
| 18-235148 | 4.5MM Ø 48MM LENGTH | In distribution |
| 18-235126 | 4.5MM Ø 26MM LENGTH | In distribution |
| 18-235158 | 4.5MM Ø 58MM LENGTH | 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 |
| 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
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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2008-09-24 | Not classified | Labeling mix-ups | The outer package is properly labeled, but the inner package may be labeled as a femoral component. | 48 | 2009-06-29 |
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.