Appliance, Fixation, Spinal Interlaminal
OC-tap, flexible, for CS 3914-50-XX, coupling AO
11manufacturers in China registered for this device type
26catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Ulrich Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K150650 |
| Record published | 2016-07-30 |
| Record revised | 2026-06-10 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-02-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS 3933 | In distribution | |
| CS 3929-04 | In distribution | |
| CS 3938-03 | In distribution | |
| CS 3929-02 | In distribution | |
| CS 3939-01 | In distribution | |
| CS 3938-06 | In distribution | |
| CS 3954-03 | In distribution | |
| CS 3995-002-000 | In distribution | |
| CS 3921-02 | In distribution | |
| CS 3995-001-001 | In distribution | |
| CS 3993-900 | In distribution | |
| CS 3961 | In distribution | |
| CS 3952-01 | In distribution | |
| CS 3952-02 | In distribution | |
| CS 3994-001-004 | In distribution | |
| CS 3995-003-000 | In distribution | |
| CS 3945-01 | In distribution | |
| CS 3954-01 | In distribution | |
| CS 1447-1 | Withdrawn | |
| CS 1440-6 | Withdrawn | |
| CS 1448 | Withdrawn | |
| CS 1440-2 | Withdrawn | |
| CS 1440-3 | Withdrawn | |
| CS 1440-1 | Withdrawn | |
| CS 1447-2 | Withdrawn | |
| CS 1440-5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113346 | 2012-02-28 |
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 |
|---|---|---|---|---|---|---|---|
| Ulrich Medical USA, Inc. | 510(k) number | 2019-12-31 | Class II | Process control | Due to a production error, the weld seam of the “Locking screw for crosslink, screw-to-screw” cannot reliably transmit the required torque of 3.5 Nm during installation. | 179 units | 2025-11-17 |
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.