Epic™ Anterior Thoracolumbar Plate System
236 catalogue numbers from 5021-6020, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
236catalogue numbers in this listing
2510(k) clearances naming this product 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 | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2020-06-26 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5021-6020 | Screw Fixed Blunt Ø6.0x20mm | In distribution |
| 5003-0360 | PLATE SACRAL TI 36MM | In distribution |
| 5010-7030 | SCREW RESCUE FIXED SELF DRILL Ø7.0X30MM | In distribution |
| 5012-7032 | Screw Rescue Fixed Blunt Ø6.0x32mm | In distribution |
| 5001-1440 | COVER PLATE TI 44MM | In distribution |
| 5011-6036 | Screw Variable Self Drilling Ø6.0x36mm | In distribution |
| 5003-0420 | Plate Sacral Ti 42mm | In distribution |
| 5010-7036 | Screw Rescue Fixed Self Drill Ø7.0x36mm | In distribution |
| 5003-0460 | Plate Sacral Ti 46mm | In distribution |
| 5003-0360 | Plate Sacral Ti 36mm | In distribution |
| 5015-6024 | SCREW VARIABLE SELF-TAP TI Ø6.0X24MM | In distribution |
| 5013-6026 | SCREW VARIABLE BLUNT Ø6.0X26MM | In distribution |
| 5003-0320 | Plate Sacral Ti 32mm | In distribution |
| 5015-6024 | Screw Variable Self-Tap Ti Ø6.0x24mm | In distribution |
| 5021-6034 | SCREW FIXED BLUNT Ø6.0X34MM | In distribution |
| 5011-6030 | Screw Variable Self Drilling Ø6.0x30mm | In distribution |
| 5014-7032 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X32MM | In distribution |
| 5020-6030 | SCREW FIXED SELF DRILLING Ø6.0X30MM | In distribution |
| 5014-7036 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X36MM | In distribution |
| 5017-6036 | SCREW FIXED SELF-TAP TI Ø6.0X36MM | In distribution |
| 5013-6024 | SCREW VARIABLE BLUNT Ø6.0X24MM | In distribution |
| 5003-0440 | Plate Sacral Ti 44mm | In distribution |
| 5012-7030 | SCREW RESCUE FIXED BLUNT Ø6.0X30MM | In distribution |
| 5011-6022 | SCREW VARIABLE SELF DRILLING Ø6.0X22MM | In distribution |
| 5001-1440 | Cover Plate Ti 44mm | In distribution |
| 5001-0400 | Plate Ti 40mm | In distribution |
| 5011-6036 | SCREW VARIABLE SELF DRILLING Ø6.0X36MM | In distribution |
| 5017-6020 | SCREW FIXED SELF-TAP TI Ø6.0X20MM | In distribution |
| 5021-6024 | SCREW FIXED BLUNT Ø6.0X24MM | In distribution |
| 5010-7020 | SCREW RESCUE FIXED SELF DRILL Ø7.0X20MM | In distribution |
| 5014-7032 | Screw Rescue Fixed Self-Tap Ti Ø7.0x32mm | In distribution |
| 5017-6022 | Screw Fixed Self-Tap Ti Ø6.0x22mm | In distribution |
| 5001-0460 | PLATE TI 46MM | In distribution |
| 5001-0340 | Plate Ti 34mm | In distribution |
| 5001-1500 | Cover Plate Ti 50mm | In distribution |
| 5011-6022 | Screw Variable Self Drilling Ø6.0x22mm | In distribution |
| 5013-6034 | Screw Variable Blunt Ø6.0x34mm | In distribution |
| 5001-1300 | COVER PLATE TI 30MM | In distribution |
| 5012-7020 | Screw Rescue Fixed Blunt Ø6.0x20mm | In distribution |
| 5020-6020 | SCREW FIXED SELF DRILLING Ø6.0X20MM | In distribution |
| 5003-0280 | Plate Sacral Ti 28mm | In distribution |
| 5017-6032 | SCREW FIXED SELF-TAP TI Ø6.0X32MM | In distribution |
| 5020-6026 | Screw Fixed Self Drilling Ø6.0x26mm | In distribution |
| 5017-6036 | Screw Fixed Self-Tap Ti Ø6.0x36mm | In distribution |
| 5021-6028 | SCREW FIXED BLUNT Ø6.0X28MM | In distribution |
| 5020-6036 | Screw Fixed Self Drilling Ø6.0x36mm | In distribution |
| 5001-1400 | COVER PLATE TI 40MM | In distribution |
| 5017-6022 | SCREW FIXED SELF-TAP TI Ø6.0X22MM | In distribution |
| 5021-6026 | Screw Fixed Blunt Ø6.0x26mm | In distribution |
| 5014-7028 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X28MM | In distribution |
| 5001-1380 | Cover Plate Ti 38mm | In distribution |
| 5014-7024 | Screw Rescue Fixed Self-Tap Ti Ø7.0x24mm | In distribution |
| 5021-6026 | SCREW FIXED BLUNT Ø6.0X26MM | In distribution |
| 5003-0500 | PLATE SACRAL TI 50MM | In distribution |
| 5013-6028 | Screw Variable Blunt Ø6.0x28mm | In distribution |
| 5012-7026 | SCREW RESCUE FIXED BLUNT Ø6.0X26MM | In distribution |
| 5017-6032 | Screw Fixed Self-Tap Ti Ø6.0x32mm | In distribution |
| 5014-7022 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X22MM | In distribution |
| 5017-6024 | Screw Fixed Self-Tap Ti Ø6.0x24mm | In distribution |
| 5017-6024 | SCREW FIXED SELF-TAP TI Ø6.0X24MM | In distribution |
| 5020-6034 | Screw Fixed Self Drilling Ø6.0x34mm | In distribution |
| 5001-1420 | COVER PLATE TI 42MM | In distribution |
| 5014-7030 | Screw Rescue Fixed Self-Tap Ti Ø7.0x30mm | In distribution |
| 5003-0480 | Plate Sacral Ti 48mm | In distribution |
| 5012-7020 | SCREW RESCUE FIXED BLUNT Ø6.0X20MM | In distribution |
| 5015-6034 | Screw Variable Self-Tap Ti Ø6.0x34mm | In distribution |
| 5020-6028 | Screw Fixed Self Drilling Ø6.0x28mm | In distribution |
| 5020-6026 | SCREW FIXED SELF DRILLING Ø6.0X26MM | In distribution |
| 5015-6022 | Screw Variable Self-Tap Ti Ø6.0x22mm | In distribution |
| 5015-6026 | Screw Variable Self-Tap Ti Ø6.0x26mm | In distribution |
| 5001-0420 | PLATE TI 42MM | In distribution |
| 5012-7030 | Screw Rescue Fixed Blunt Ø6.0x30mm | In distribution |
| 5001-0300 | Plate Ti 30mm | In distribution |
| 5011-6026 | Screw Variable Self Drilling Ø6.0x26mm | In distribution |
| 5020-6030 | Screw Fixed Self Drilling Ø6.0x30mm | In distribution |
| 5003-0440 | PLATE SACRAL TI 44MM | In distribution |
| 5010-7034 | Screw Rescue Fixed Self Drill Ø7.0x34mm | In distribution |
| 5013-6026 | Screw Variable Blunt Ø6.0x26mm | In distribution |
| 5011-6030 | SCREW VARIABLE SELF DRILLING Ø6.0X30MM | In distribution |
| 5001-0380 | PLATE TI 38MM | In distribution |
| 5017-6026 | SCREW FIXED SELF-TAP TI Ø6.0X26MM | In distribution |
| 5013-6030 | Screw Variable Blunt Ø6.0x30mm | In distribution |
| 5020-6028 | SCREW FIXED SELF DRILLING Ø6.0X28MM | In distribution |
| 5011-6028 | SCREW VARIABLE SELF DRILLING Ø6.0X28MM | In distribution |
| 5010-7032 | Screw Rescue Fixed Self Drill Ø7.0x32mm | In distribution |
| 5014-7034 | Screw Rescue Fixed Self-Tap Ti Ø7.0x34mm | In distribution |
| 5015-6020 | Screw Variable Self-Tap Ti Ø6.0x20mm | In distribution |
| 5001-1400 | Cover Plate Ti 40mm | In distribution |
| 5021-6028 | Screw Fixed Blunt Ø6.0x28mm | In distribution |
| 5013-6022 | Screw Variable Blunt Ø6.0x22mm | In distribution |
| 5013-6028 | SCREW VARIABLE BLUNT Ø6.0X28MM | In distribution |
| 5013-6024 | Screw Variable Blunt Ø6.0x24mm | In distribution |
| 5015-6026 | SCREW VARIABLE SELF-TAP TI Ø6.0X26MM | In distribution |
| 5015-6028 | SCREW VARIABLE SELF-TAP TI Ø6.0X28MM | In distribution |
| 5021-6022 | Screw Fixed Blunt Ø6.0x22mm | In distribution |
| 5021-6024 | Screw Fixed Blunt Ø6.0x24mm | In distribution |
| 5003-0420 | PLATE SACRAL TI 42MM | In distribution |
| 5020-6024 | SCREW FIXED SELF DRILLING Ø6.0X24MM | In distribution |
| 5001-0480 | Plate Ti 48mm | In distribution |
| 5020-6024 | Screw Fixed Self Drilling Ø6.0x24mm | In distribution |
| 5020-6022 | SCREW FIXED SELF DRILLING Ø6.0X22MM | In distribution |
| 5013-6034 | SCREW VARIABLE BLUNT Ø6.0X34MM | In distribution |
| 5010-7026 | Screw Rescue Fixed Self Drill Ø7.0x26mm | In distribution |
| 5011-6028 | Screw Variable Self Drilling Ø6.0x28mm | In distribution |
| 5003-0320 | PLATE SACRAL TI 32MM | In distribution |
| 5021-6030 | Screw Fixed Blunt Ø6.0x30mm | In distribution |
| 5011-6034 | Screw Variable Self Drilling Ø6.0x34mm | In distribution |
| 5012-7022 | SCREW RESCUE FIXED BLUNT Ø6.0X22MM | In distribution |
| 5015-6030 | SCREW VARIABLE SELF-TAP TI Ø6.0X30MM | In distribution |
| 5001-0400 | PLATE TI 40MM | In distribution |
| 5001-1360 | Cover Plate Ti 36mm | In distribution |
| 5003-0340 | Plate Sacral Ti 34mm | In distribution |
| 5020-6034 | SCREW FIXED SELF DRILLING Ø6.0X34MM | In distribution |
| 5001-1340 | COVER PLATE TI 34MM | In distribution |
| 5001-0280 | Plate Ti 28mm | In distribution |
| 5001-0280 | PLATE TI 28MM | In distribution |
| 5005-0002 | Cover Plate Fastener Ti | In distribution |
| 5020-6022 | Screw Fixed Self Drilling Ø6.0x22mm | In distribution |
| 5014-7028 | Screw Rescue Fixed Self-Tap Ti Ø7.0x28mm | In distribution |
| 5021-6036 | Screw Fixed Blunt Ø6.0x36mm | In distribution |
| 5020-6036 | SCREW FIXED SELF DRILLING Ø6.0X36MM | In distribution |
| 5001-0480 | PLATE TI 48MM | In distribution |
| 5014-7020 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X20MM | In distribution |
| 5011-6032 | SCREW VARIABLE SELF DRILLING Ø6.0X32MM | In distribution |
| 5011-6026 | SCREW VARIABLE SELF DRILLING Ø6.0X26MM | In distribution |
| 5013-6020 | Screw Variable Blunt Ø6.0x20mm | In distribution |
| 5001-1420 | Cover Plate Ti 42mm | In distribution |
| 5015-6036 | Screw Variable Self-Tap Ti Ø6.0x36mm | In distribution |
| 5012-7032 | SCREW RESCUE FIXED BLUNT Ø6.0X32MM | In distribution |
| 5001-0380 | Plate Ti 38mm | In distribution |
| 5017-6026 | Screw Fixed Self-Tap Ti Ø6.0x26mm | In distribution |
| 5017-6028 | Screw Fixed Self-Tap Ti Ø6.0x28mm | In distribution |
| 5001-1280 | Cover Plate Ti 28mm | In distribution |
| 5021-6022 | SCREW FIXED BLUNT Ø6.0X22MM | In distribution |
| 5015-6032 | Screw Variable Self-Tap Ti Ø6.0x32mm | In distribution |
| 5013-6022 | SCREW VARIABLE BLUNT Ø6.0X22MM | In distribution |
| 5011-6020 | SCREW VARIABLE SELF DRILLING Ø6.0X20MM | In distribution |
| 5005-0002 | COVER PLATE FASTENER TI | In distribution |
| 5013-6036 | SCREW VARIABLE BLUNT Ø6.0X36MM | In distribution |
| 5001-0440 | Plate Ti 44mm | In distribution |
| 5011-6024 | SCREW VARIABLE SELF DRILLING Ø6.0X24MM | In distribution |
| 5001-0440 | PLATE TI 44MM | In distribution |
| 5014-7022 | Screw Rescue Fixed Self-Tap Ti Ø7.0x22mm | In distribution |
| 5001-1380 | COVER PLATE TI 38MM | In distribution |
| 5003-0380 | Plate Sacral Ti 38mm | In distribution |
| 5001-1480 | Cover Plate Ti 48mm | In distribution |
| 5001-0300 | PLATE TI 30MM | In distribution |
| 5010-7036 | SCREW RESCUE FIXED SELF DRILL Ø7.0X36MM | In distribution |
| 5003-0480 | PLATE SACRAL TI 48MM | In distribution |
| 5011-6034 | SCREW VARIABLE SELF DRILLING Ø6.0X34MM | In distribution |
| 5010-7024 | Screw Rescue Fixed Self Drill Ø7.0x24mm | In distribution |
| 5010-7022 | Screw Rescue Fixed Self Drill Ø7.0x22mm | In distribution |
| 5001-0320 | PLATE TI 32MM | In distribution |
| 5001-0340 | PLATE TI 34MM | In distribution |
| 5012-7024 | Screw Rescue Fixed Blunt Ø6.0x24mm | In distribution |
| 5012-7036 | SCREW RESCUE FIXED BLUNT Ø6.0X36MM | In distribution |
| 5011-6020 | Screw Variable Self Drilling Ø6.0x20mm | In distribution |
| 5013-6036 | Screw Variable Blunt Ø6.0x36mm | In distribution |
| 5003-0400 | PLATE SACRAL TI 40MM | In distribution |
| 5014-7020 | Screw Rescue Fixed Self-Tap Ti Ø7.0x20mm | In distribution |
| 5001-0460 | Plate Ti 46mm | In distribution |
| 5014-7024 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X24MM | In distribution |
| 5013-6032 | Screw Variable Blunt Ø6.0x32mm | In distribution |
| 5012-7022 | Screw Rescue Fixed Blunt Ø6.0x22mm | In distribution |
| 5020-6032 | Screw Fixed Self Drilling Ø6.0x32mm | In distribution |
| 5001-0500 | PLATE TI 50MM | In distribution |
| 5012-7034 | Screw Rescue Fixed Blunt Ø6.0x34mm | In distribution |
| 5001-1280 | COVER PLATE TI 28MM | In distribution |
| 5017-6020 | Screw Fixed Self-Tap Ti Ø6.0x20mm | In distribution |
| 5003-0400 | Plate Sacral Ti 40mm | In distribution |
| 5001-1320 | COVER PLATE TI 32MM | In distribution |
| 5001-0500 | Plate Ti 50mm | In distribution |
| 5017-6034 | SCREW FIXED SELF-TAP TI Ø6.0X34MM | In distribution |
| 5014-7026 | Screw Rescue Fixed Self-Tap Ti Ø7.0x26mm | In distribution |
| 5017-6030 | SCREW FIXED SELF-TAP TI Ø6.0X30MM | In distribution |
| 5012-7028 | Screw Rescue Fixed Blunt Ø6.0x28mm | In distribution |
| 5001-0360 | PLATE TI 36MM | In distribution |
| 5014-7030 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X30MM | In distribution |
| 5020-6020 | Screw Fixed Self Drilling Ø6.0x20mm | In distribution |
| 5001-1500 | COVER PLATE TI 50MM | In distribution |
| 5015-6034 | SCREW VARIABLE SELF-TAP TI Ø6.0X34MM | In distribution |
| 5010-7022 | SCREW RESCUE FIXED SELF DRILL Ø7.0X22MM | In distribution |
| 5003-0500 | Plate Sacral Ti 50mm | In distribution |
| 5010-7034 | SCREW RESCUE FIXED SELF DRILL Ø7.0X34MM | In distribution |
| 5021-6020 | SCREW FIXED BLUNT Ø6.0X20MM | In distribution |
| 5021-6030 | SCREW FIXED BLUNT Ø6.0X30MM | In distribution |
| 5015-6028 | Screw Variable Self-Tap Ti Ø6.0x28mm | In distribution |
| 5013-6030 | SCREW VARIABLE BLUNT Ø6.0X30MM | In distribution |
| 5010-7024 | SCREW RESCUE FIXED SELF DRILL Ø7.0X24MM | In distribution |
| 5010-7032 | SCREW RESCUE FIXED SELF DRILL Ø7.0X32MM | In distribution |
| 5010-7028 | Screw Rescue Fixed Self Drill Ø7.0x28mm | In distribution |
| 5021-6036 | SCREW FIXED BLUNT Ø6.0X36MM | In distribution |
| 5012-7036 | Screw Rescue Fixed Blunt Ø6.0x36mm | In distribution |
| 5010-7028 | SCREW RESCUE FIXED SELF DRILL Ø7.0X28MM | In distribution |
| 5003-0340 | PLATE SACRAL TI 34MM | In distribution |
| 5011-6024 | Screw Variable Self Drilling Ø6.0x24mm | In distribution |
| 5015-6032 | SCREW VARIABLE SELF-TAP TI Ø6.0X32MM | In distribution |
| 5014-7036 | Screw Rescue Fixed Self-Tap Ti Ø7.0x36mm | In distribution |
| 5021-6032 | SCREW FIXED BLUNT Ø6.0X32MM | In distribution |
| 5001-1460 | Cover Plate Ti 46mm | In distribution |
| 5010-7030 | Screw Rescue Fixed Self Drill Ø7.0x30mm | In distribution |
| 5001-1480 | COVER PLATE TI 48MM | In distribution |
| 5015-6022 | SCREW VARIABLE SELF-TAP TI Ø6.0X22MM | In distribution |
| 5014-7026 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X26MM | In distribution |
| 5015-6030 | Screw Variable Self-Tap Ti Ø6.0x30mm | In distribution |
| 5001-0320 | Plate Ti 32mm | In distribution |
| 5001-1340 | Cover Plate Ti 34mm | In distribution |
| 5021-6034 | Screw Fixed Blunt Ø6.0x34mm | In distribution |
| 5015-6020 | SCREW VARIABLE SELF-TAP TI Ø6.0X20MM | In distribution |
| 5001-0420 | Plate Ti 42mm | In distribution |
| 5017-6030 | Screw Fixed Self-Tap Ti Ø6.0x30mm | In distribution |
| 5013-6020 | SCREW VARIABLE BLUNT Ø6.0X20MM | In distribution |
| 5013-6032 | SCREW VARIABLE BLUNT Ø6.0X32MM | In distribution |
| 5010-7020 | Screw Rescue Fixed Self Drill Ø7.0x20mm | In distribution |
| 5012-7034 | SCREW RESCUE FIXED BLUNT Ø6.0X34MM | In distribution |
| 5010-7026 | SCREW RESCUE FIXED SELF DRILL Ø7.0X26MM | In distribution |
| 5003-0280 | PLATE SACRAL TI 28MM | In distribution |
| 5001-0360 | Plate Ti 36mm | In distribution |
| 5003-0300 | PLATE SACRAL TI 30MM | In distribution |
| 5015-6036 | SCREW VARIABLE SELF-TAP TI Ø6.0X36MM | In distribution |
| 5001-1460 | COVER PLATE TI 46MM | In distribution |
| 5017-6034 | Screw Fixed Self-Tap Ti Ø6.0x34mm | In distribution |
| 5003-0380 | PLATE SACRAL TI 38MM | In distribution |
| 5003-0300 | Plate Sacral Ti 30mm | In distribution |
| 5012-7026 | Screw Rescue Fixed Blunt Ø6.0x26mm | In distribution |
| 5021-6032 | Screw Fixed Blunt Ø6.0x32mm | In distribution |
| 5017-6028 | SCREW FIXED SELF-TAP TI Ø6.0X28MM | In distribution |
| 5020-6032 | SCREW FIXED SELF DRILLING Ø6.0X32MM | In distribution |
| 5001-1300 | Cover Plate Ti 30mm | In distribution |
| 5001-1360 | COVER PLATE TI 36MM | In distribution |
| 5001-1320 | Cover Plate Ti 32mm | In distribution |
| 5003-0460 | PLATE SACRAL TI 46MM | In distribution |
| 5012-7028 | SCREW RESCUE FIXED BLUNT Ø6.0X28MM | In distribution |
| 5014-7034 | SCREW RESCUE FIXED SELF-TAP TI Ø7.0X34MM | In distribution |
| 5011-6032 | Screw Variable Self Drilling Ø6.0x32mm | In distribution |
| 5012-7024 | SCREW RESCUE FIXED BLUNT Ø6.0X24MM | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.