Songer® Spinal Cable System
(1) Ø1.25mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round
5manufacturers in China registered for this device type
60catalogue numbers in this listing
13510(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 | Pioneer Surgical Technology, Inc., United States |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K935481 |
| Record published | 2016-06-25 |
| Record revised | 2026-02-09 (version 7) |
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, manufacturing date |
| Distribution end date | 2022-11-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400-201 | In distribution | |
| 400-101 | In distribution | |
| 400-114 | In distribution | |
| 400-105 | In distribution | |
| 400-100 | In distribution | |
| 400-205 | In distribution | |
| 400-104 | In distribution | |
| 400-211 | In distribution | |
| 400-115 | In distribution | |
| 400-216 | In distribution | |
| 400-207 | In distribution | |
| 400-209 | In distribution | |
| 400-213 | In distribution | |
| 400-214 | In distribution | |
| 400-218 | In distribution | |
| 400-206 | In distribution | |
| 400-204 | In distribution | |
| 400-109 | In distribution | |
| 400-200 | In distribution | |
| 400-212 | In distribution | |
| 400-107 | In distribution | |
| 400-112 | In distribution | |
| 400-210 | In distribution | |
| 400-203 | In distribution | |
| 400-219 | In distribution | |
| 400-202 | In distribution | |
| 400-113 | In distribution | |
| 400-110 | In distribution | |
| 400-106 | In distribution | |
| 400-208 | In distribution | |
| 400-111 | In distribution | |
| 400-103 | In distribution | |
| 400-102 | In distribution | |
| 400-217 | In distribution | |
| 400-108 | In distribution | |
| 186.200S | Withdrawn | |
| 401-540 | Withdrawn | |
| 286.102S | Withdrawn | |
| 00-INSTCASE | Withdrawn | |
| 400-650 | Withdrawn | |
| 686.302 | Withdrawn | |
| 400-684 | Withdrawn | |
| 286.101S | Withdrawn | |
| 400-654 | Withdrawn | |
| 286.100S | Withdrawn | |
| 686.303 | Withdrawn | |
| 186.201S | Withdrawn | |
| 186.202S | Withdrawn | |
| 686.304 | Withdrawn | |
| 400-655 | Withdrawn | |
| 986.1 | Withdrawn | |
| 400-645 | Withdrawn | |
| 400-651 | Withdrawn | |
| 686.301 | Withdrawn | |
| 400-646 | Withdrawn | |
| 400-685 | Withdrawn | |
| 686.303 | Withdrawn | |
| 400-648 | Withdrawn | |
| 400-649 | Withdrawn | |
| 400-908 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cerclage, Fixation | Synthes Gmbh | 102 |
| Optilink | Synthes Gmbh | 61 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261271 | 2026-07-16 |
| K133785 | 2014-01-27 |
| K002110 | 2000-10-06 |
| K001709 | 2000-08-31 |
| K993286 | 1999-11-23 |
| K992616 | 1999-10-27 |
| K980690 | 1998-05-22 |
| K974016 | 1997-12-19 |
| K961267 | 1996-06-27 |
| K940729 | 1994-12-21 |
| K941213 | 1994-04-19 |
| K935481 | 1994-01-26 |
| K922952 | 1993-02-23 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-05-29 | Class II | Labeling Change Control | The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc. | 25 | 2016-03-17 |
| 2014-06-11 | Class II | Employee error | Lack of Sterility Assurance | 5 | 2014-10-22 |
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.