Expedium SFX
EXPEDIUM SFX CROSS CONNECTOR SYSTEM LATERAL CONNECTOR - F14 6.35 x 50mm
7manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Depuy Spine, Inc., United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K070300 |
| Record published | 2015-09-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
| Distribution end date | 2018-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 189407119 | In distribution | |
| 189401303 | In distribution | |
| 189403208 | In distribution | |
| 189407113 | In distribution | |
| 189407120 | In distribution | |
| 189401301 | In distribution | |
| 189401108 | In distribution | |
| 189403407 | In distribution | |
| 189403206 | In distribution | |
| 189407234 | In distribution | |
| 189403303 | In distribution | |
| 189407118 | In distribution | |
| 189404303 | Withdrawn | |
| 189404106 | Withdrawn | |
| 189408226 | Withdrawn | |
| 189408120 | Withdrawn | |
| 189404114 | Withdrawn | |
| 189402404 | Withdrawn | |
| 189402302 | Withdrawn | |
| 189407254 | Withdrawn | |
| 189404102 | Withdrawn | |
| 189402407 | Withdrawn | |
| 189408232 | Withdrawn | |
| 189404111 | Withdrawn | |
| 189402105 | Withdrawn | |
| 189405100 | Withdrawn | |
| 189404105 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Spine, Inc. | 510(k) number | 2015-04-21 | Class II | Process design | Device does not mate as intended. | 183 devices | 2018-10-03 |
| Depuy Spine, Inc. | 510(k) number | 2009-02-11 | Not classified | Nonconforming Material/Component | Tip of Driver may break during use | 117 units | 2015-07-09 |
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.