Epic Anterior Thoracolumbar Plate System
Screw Rescue Fixed Self-Tap Ti Ø7.0x26mm
14manufacturers in China registered for this device type
117catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-11-14 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5021-6032 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x32mm | In distribution |
| 5001-1280 | Device Size Text, specify—Cover Plate Ti 28mm | In distribution |
| 5011-6024 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x24mm | In distribution |
| 5021-6022 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x22mm | In distribution |
| 5021-6024 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x24mm | In distribution |
| 5011-6026 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x26mm | In distribution |
| 5011-6020 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x20mm | In distribution |
| 5013-6030 | Device Size Text, specify—Screw Variable Blunt Ø6.0x30mm | In distribution |
| 5017-6022 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x22mm | In distribution |
| 5017-6036 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x36mm | In distribution |
| 5001-1380 | Device Size Text, specify—Cover Plate Ti 38mm | In distribution |
| 5001-1400 | Device Size Text, specify—Cover Plate Ti 40mm | In distribution |
| 5015-6036 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x36mm | In distribution |
| 5003-0380 | Device Size Text, specify—Plate Sacral Ti 38mm | In distribution |
| 5021-6026 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x26mm | In distribution |
| 5001-0480 | Device Size Text, specify—Plate Ti 48mm | In distribution |
| 5001-0400 | Device Size Text, specify—Plate Ti 40mm | In distribution |
| 5011-6030 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x30mm | In distribution |
| 5001-1420 | Device Size Text, specify—Cover Plate Ti 42mm | In distribution |
| 5021-6020 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x20mm | In distribution |
| 5001-1480 | Device Size Text, specify—Cover Plate Ti 48mm | In distribution |
| 5001-0360 | Device Size Text, specify—Plate Ti 36mm | In distribution |
| 5020-6028 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x28mm | In distribution |
| 5003-0400 | Device Size Text, specify—Plate Sacral Ti 40mm | In distribution |
| 5021-6028 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x28mm | In distribution |
| 5011-6022 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x22mm | In distribution |
| 5010-7024 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x24mm | In distribution |
| 5012-7032 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x32mm | In distribution |
| 5015-6032 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x32mm | In distribution |
| 5021-6036 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x36mm | In distribution |
| 5003-0460 | Device Size Text, specify—Plate Sacral Ti 46mm | In distribution |
| 5015-6020 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x20mm | In distribution |
| 5020-6036 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x36mm | In distribution |
| 5011-6036 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x36mm | In distribution |
| 5010-7026 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x26mm | In distribution |
| 5014-7026 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x26mm | In distribution |
| 5010-7036 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x36mm | In distribution |
| 5013-6032 | Device Size Text, specify—Screw Variable Blunt Ø6.0x32mm | In distribution |
| 5013-6020 | Device Size Text, specify—Screw Variable Blunt Ø6.0x20mm | In distribution |
| 5012-7026 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x26mm | In distribution |
| 5001-0340 | Device Size Text, specify—Plate Ti 34mm | In distribution |
| 5001-1360 | Device Size Text, specify—Cover Plate Ti 36mm | In distribution |
| 5014-7028 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x28mm | In distribution |
| 5001-0380 | Device Size Text, specify—Plate Ti 38mm | In distribution |
| 5001-0320 | Device Size Text, specify—Plate Ti 32mm | In distribution |
| 5014-7036 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x36mm | In distribution |
| 5021-6030 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x30mm | In distribution |
| 5012-7028 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x28mm | In distribution |
| 5010-7030 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x30mm | In distribution |
| 5020-6034 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x34mm | In distribution |
| 5017-6034 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x34mm | In distribution |
| 5020-6030 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x30mm | In distribution |
| 5017-6028 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x28mm | In distribution |
| 5001-0460 | Device Size Text, specify—Plate Ti 46mm | In distribution |
| 5014-7030 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x30mm | In distribution |
| 5013-6028 | Device Size Text, specify—Screw Variable Blunt Ø6.0x28mm | In distribution |
| 5013-6034 | Device Size Text, specify—Screw Variable Blunt Ø6.0x34mm | In distribution |
| 5005-0002 | Device Size Text, specify—Cover Plate Fastener Ti | In distribution |
| 5015-6026 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x26mm | In distribution |
| 5001-0280 | Device Size Text, specify—Plate Ti 28mm | In distribution |
| 5017-6030 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x30mm | In distribution |
| 5012-7022 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x22mm | In distribution |
| 5010-7020 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x20mm | In distribution |
| 5014-7020 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x20mm | In distribution |
| 5017-6020 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x20mm | In distribution |
| 5001-1500 | Device Size Text, specify—Cover Plate Ti 50mm | In distribution |
| 5020-6032 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x32mm | In distribution |
| 5003-0300 | Device Size Text, specify—Plate Sacral Ti 30mm | In distribution |
| 5015-6034 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x34mm | In distribution |
| 5020-6024 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x24mm | In distribution |
| 5014-7024 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x24mm | In distribution |
| 5003-0360 | Device Size Text, specify—Plate Sacral Ti 36mm | In distribution |
| 5021-6034 | Device Size Text, specify—Screw Fixed Blunt Ø6.0x34mm | In distribution |
| 5001-0420 | Device Size Text, specify—Plate Ti 42mm | In distribution |
| 5014-7034 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x34mm | In distribution |
| 5003-0340 | Device Size Text, specify—Plate Sacral Ti 34mm | In distribution |
| 5003-0320 | Device Size Text, specify—Plate Sacral Ti 32mm | In distribution |
| 5003-0280 | Device Size Text, specify—Plate Sacral Ti 28mm | In distribution |
| 5015-6022 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x22mm | In distribution |
| 5001-1440 | Device Size Text, specify—Cover Plate Ti 44mm | In distribution |
| 5003-0420 | Device Size Text, specify—Plate Sacral Ti 42mm | In distribution |
| 5017-6032 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x32mm | In distribution |
| 5014-7032 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x32mm | In distribution |
| 5010-7032 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x32mm | In distribution |
| 5012-7020 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x20mm | In distribution |
| 5013-6024 | Device Size Text, specify—Screw Variable Blunt Ø6.0x24mm | In distribution |
| 5017-6026 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x26mm | In distribution |
| 5013-6026 | Device Size Text, specify—Screw Variable Blunt Ø6.0x26mm | In distribution |
| 5015-6028 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x28mm | In distribution |
| 5013-6022 | Device Size Text, specify—Screw Variable Blunt Ø6.0x22mm | In distribution |
| 5010-7034 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x34mm | In distribution |
| 5001-1300 | Device Size Text, specify—Cover Plate Ti 30mm | In distribution |
| 5011-6032 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x32mm | In distribution |
| 5013-6036 | Device Size Text, specify—Screw Variable Blunt Ø6.0x36mm | In distribution |
| 5015-6030 | Device Size Text, specify—Screw Variable Self-Tap Ti Ø6.0x30mm | In distribution |
| 5003-0500 | Device Size Text, specify—Plate Sacral Ti 50mm | In distribution |
| 5011-6034 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x34mm | In distribution |
| 5003-0440 | Device Size Text, specify—Plate Sacral Ti 44mm | In distribution |
| 5014-7022 | Device Size Text, specify—Screw Rescue Fixed Self-Tap Ti Ø7.0x22mm | In distribution |
| 5001-0500 | Device Size Text, specify—Plate Ti 50mm | In distribution |
| 5001-0440 | Device Size Text, specify—Plate Ti 44mm | In distribution |
| 5020-6022 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x22mm | In distribution |
| 5001-1460 | Device Size Text, specify—Cover Plate Ti 46mm | In distribution |
| 5017-6024 | Device Size Text, specify—Screw Fixed Self-Tap Ti Ø6.0x24mm | In distribution |
| 5003-0480 | Device Size Text, specify—Plate Sacral Ti 48mm | In distribution |
| 5012-7034 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x34mm | In distribution |
| 5010-7022 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x22mm | In distribution |
| 5012-7024 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x24mm | In distribution |
| 5010-7028 | Device Size Text, specify—Screw Rescue Fixed Self Drill Ø7.0x28mm | In distribution |
| 5012-7036 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x36mm | In distribution |
| 5001-0300 | Device Size Text, specify—Plate Ti 30mm | In distribution |
| 5011-6028 | Device Size Text, specify—Screw Variable Self Drilling Ø6.0x28mm | In distribution |
| 5001-1320 | Device Size Text, specify—Cover Plate Ti 32mm | In distribution |
| 5020-6026 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x26mm | In distribution |
| 5012-7030 | Device Size Text, specify—Screw Rescue Fixed Blunt Ø6.0x30mm | In distribution |
| 5001-1340 | Device Size Text, specify—Cover Plate Ti 34mm | In distribution |
| 5020-6020 | Device Size Text, specify—Screw Fixed Self Drilling Ø6.0x20mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
Recalls
3 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 |
|---|---|---|---|---|---|
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2015-09-29 | Class II | Labeling mix-ups | The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. | 17 units | 2016-04-29 |
| 2015-08-05 | Class II | Labeling mix-ups | Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. | 7 parts | 2016-02-10 |
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.