Cure™ ACP
Cure ACP is an anterior cervical plate-and-screw system that stabilizes the spine while a fusion develops. It is intended for skeletally mature patients at cervical levels C2 through C7.…
Cure ACP is an anterior cervical plate-and-screw system that stabilizes the spine while a fusion develops. It is intended for skeletally mature patients at cervical levels C2 through C7.
The implants are Grade 23 Ti-6Al-4V ELI titanium alloy. A central locking mechanism is designed to keep the bone screws in place within the plate construct.
Plate and Screw Options
Plates are offered in a range of sizes, with screws in multiple lengths and diameters. These options accommodate the surgical approach and anatomical fixation needed. The plate provides the anterior framework, while the screws anchor and lock the selected construct.
14manufacturers in China registered for this device type
503catalogue numbers in this listing
6510(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 | Meditech Spine, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K160604 |
| Record published | 2016-10-10 |
| Record revised | 2022-09-16 (version 9) |
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, serial number |
| Packaging | Pack of 4, pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T-7-40044-103 | In distribution | |
| 7-00001-23 | In distribution | |
| S1-7-00004-66 | In distribution | |
| S1-7-00003-53 | In distribution | |
| S1-7-00004-92 | In distribution | |
| S1-7-41241-10 | In distribution | |
| T-7-40044-106 | In distribution | |
| 7-00004-61 | In distribution | |
| T-7-40044-57 | In distribution | |
| S1-7-00001-26 | In distribution | |
| 700-440-00 | In distribution | |
| 7-00003-57 | In distribution | |
| S1-7-00004-60 | In distribution | |
| 7-00004-70 | In distribution | |
| T-7-40043-48 | In distribution | |
| T-7-40044-87 | In distribution | |
| S1-7-00004-98 | In distribution | |
| T-7-40041-27 | In distribution | |
| T-7-40044-66 | In distribution | |
| 7-00002-37 | In distribution | |
| T-7-40044-102 | In distribution | |
| S1-7-00003-56 | In distribution | |
| S1-7-00004-86 | In distribution | |
| S1-7-00004-100 | In distribution | |
| 7-00001-22 | In distribution | |
| T-7-40044-82 | In distribution | |
| S1-7-42145-20 | In distribution | |
| S1-7-00001-28 | In distribution | |
| 7-42145-12 | In distribution | |
| 700-430-18 | In distribution | |
| S1-700-430-14 | In distribution | |
| S1-7-42241-20 | In distribution | |
| T-7-40043-49 | In distribution | |
| S1-7-00004-70 | In distribution | |
| T-7-40044-69 | In distribution | |
| 900-430-50 | In distribution | |
| 7-42145-20 | In distribution | |
| 7-00004-92 | In distribution | |
| S1-7-00004-90 | In distribution | |
| S1-7-00004-65 | In distribution | |
| 7-41245-14 | In distribution | |
| S1-7-41241-20 | In distribution | |
| T2-7-40041-09 | In distribution | |
| 7-00002-35 | In distribution | |
| 7-00004-85 | In distribution | |
| 7-00003-70 | In distribution | |
| 7-00004-94 | In distribution | |
| S1-7-41241-18 | In distribution | |
| 7-00004-82 | In distribution | |
| S1-7-42241-12 | In distribution | |
| S1-7-00003-48 | In distribution | |
| 7-00004-98 | In distribution | |
| S1-7-00004-62 | In distribution | |
| 7-42245-18 | In distribution | |
| T-7-40044-73 | In distribution | |
| S1-7-00001-25 | In distribution | |
| 7-00002-40 | In distribution | |
| S1-7-00004-85 | In distribution | |
| 7-00003-51 | In distribution | |
| 7-41145-12 | In distribution | |
| S1-7-00002-38 | In distribution | |
| S1-7-42245-20 | In distribution | |
| S1-7-00003-55 | In distribution | |
| 7-41245-20 | In distribution | |
| T-7-40044-104 | In distribution | |
| 7-41241-12 | In distribution | |
| 7-00001-25 | In distribution | |
| S1-700-430-10 | In distribution | |
| 7-00003-64 | In distribution | |
| S1-7-00003-59 | In distribution | |
| 900-430-20 | In distribution | |
| S1-7-00004-73 | In distribution | |
| S1-7-42141-18 | In distribution | |
| 7-42245-20 | In distribution | |
| 700-455-00 | In distribution | |
| T-7-40044-84 | In distribution | |
| T-7-40044-74 | In distribution | |
| S1-7-00002-33 | In distribution | |
| 7-42141-12 | In distribution | |
| T-7-40044-101 | In distribution | |
| S1-7-00003-60 | In distribution | |
| S1-7-00004-75 | In distribution | |
| S1-7-00003-40 | In distribution | |
| S1-7-00002-34 | In distribution | |
| T-7-40043-57 | In distribution | |
| 7-00003-46 | In distribution | |
| 7-00004-93 | In distribution | |
| S1-7-00004-99 | In distribution | |
| 700-430-14 | In distribution | |
| 7-42241-14 | In distribution | |
| 700-470-00 | In distribution | |
| T-7-40044-89 | In distribution | |
| T-7-40042-44 | In distribution | |
| 700-435-10 | In distribution | |
| 7-00003-58 | In distribution | |
| T-7-40042-35 | In distribution | |
| T-7-40044-100 | In distribution | |
| 7-00004-88 | In distribution | |
| S1-7-00004-67 | In distribution | |
| T-7-40043-70 | In distribution | |
| T-7-40043-44 | In distribution | |
| S1-7-42245-10 | In distribution | |
| S1-7-42241-16 | In distribution | |
| T-7-40044-90 | In distribution | |
| T-7-40044-81 | In distribution | |
| S1-7-00004-103 | In distribution | |
| S1-7-00001-23 | In distribution | |
| 7-00004-83 | In distribution | |
| T-7-40044-79 | In distribution | |
| S1-7-00002-40 | In distribution | |
| 7-00003-60 | In distribution | |
| S1-7-41141-14 | In distribution | |
| 700-950-00 | In distribution | |
| S1-700-430-12 | In distribution | |
| 7-00004-99 | In distribution | |
| S1-7-00004-95 | In distribution | |
| S1-7-41145-12 | In distribution | |
| S1-7-00002-35 | In distribution | |
| T-7-40043-56 | In distribution | |
| 7-00004-95 | In distribution | |
| T-7-40044-85 | In distribution | |
| 7-00001-26 | In distribution | |
| 700-430-20 | In distribution | |
| S1-7-00004-61 | In distribution | |
| 7-41145-14 | In distribution | |
| 700-475-00 | In distribution | |
| S1-7-00001-22 | In distribution | |
| S1-7-00004-80 | In distribution | |
| T-7-40041-30 | In distribution | |
| S1-7-00001-31 | In distribution | |
| S1-7-00003-62 | In distribution | |
| S1-7-42245-18 | In distribution | |
| T-7-40044-86 | In distribution | |
| T2-7-40041-08 | In distribution | |
| T-7-40042-49 | In distribution | |
| S1-7-42141-14 | In distribution | |
| S1-7-00002-32 | In distribution | |
| 7-00004-90 | In distribution | |
| S1-7-00002-41 | In distribution | |
| T-7-40044-78 | In distribution | |
| S1-7-00004-59 | In distribution | |
| S1-7-00003-46 | In distribution | |
| T-7-40041-20 | In distribution | |
| S1-7-00003-47 | In distribution | |
| 7-00004-86 | In distribution | |
| 7-41245-16 | In distribution | |
| 7-00004-71 | In distribution | |
| 7-00002-50 | In distribution | |
| S1-7-42245-12 | In distribution | |
| 7-00002-42 | In distribution | |
| 7-00003-67 | In distribution | |
| S1-7-00001-21 | In distribution | |
| 7-41245-18 | In distribution | |
| S1-7-00004-68 | In distribution | |
| T-7-40041-23 | In distribution | |
| S1-7-00004-82 | In distribution | |
| T-7-40042-30 | In distribution | |
| S1-7-00003-52 | In distribution | |
| 7-00004-62 | In distribution | |
| S1-7-00002-49 | In distribution | |
| 7-42145-10 | In distribution | |
| S1-7-00004-97 | In distribution | |
| 7-00003-48 | In distribution | |
| S1-7-00004-105 | In distribution | |
| 7-41141-16 | In distribution | |
| 7-00003-68 | In distribution | |
| 7-00002-49 | In distribution | |
| S1-7-00002-45 | In distribution | |
| 900-430-25 | In distribution | |
| S1-7-42145-18 | In distribution | |
| 7-42245-14 | In distribution | |
| T-7-40043-52 | In distribution | |
| 7-00003-49 | In distribution | |
| S1-7-41245-12 | In distribution | |
| T-7-40042-40 | In distribution | |
| T-7-40044-60 | In distribution | |
| S1-7-41145-16 | In distribution | |
| S1-700-430-16 | In distribution | |
| S1-7-41245-16 | In distribution | |
| 7-42241-12 | In distribution | |
| 700-480-00 | In distribution | |
| S1-7-00003-68 | In distribution | |
| S1-7-00004-91 | In distribution | |
| S1-7-00003-50 | In distribution | |
| 700-410-05 | In distribution | |
| 7-00002-39 | In distribution | |
| 7-00003-63 | In distribution | |
| T-7-40042-43 | In distribution | |
| 7-42245-16 | In distribution | |
| 7-00002-48 | In distribution | |
| 7-00004-76 | In distribution | |
| S1-7-00001-20 | In distribution | |
| 7-42145-18 | In distribution | |
| 7-00004-58 | In distribution | |
| S1-7-00002-43 | In distribution | |
| 7-00003-40 | In distribution | |
| S1-7-41245-20 | In distribution | |
| T-7-40044-92 | In distribution | |
| T-7-40044-61 | In distribution | |
| 7-00002-47 | In distribution | |
| T-7-40043-60 | In distribution | |
| 7-00004-69 | In distribution | |
| 7-42245-12 | In distribution | |
| 900-430-35 | In distribution | |
| 7-00004-56 | In distribution | |
| S1-7-41241-14 | In distribution | |
| 7-41241-18 | In distribution | |
| T-7-40043-43 | In distribution | |
| T2-7-40041-05 | In distribution | |
| S1-700-435-10 | In distribution | |
| S1-7-00004-87 | In distribution | |
| T-7-40043-65 | In distribution | |
| S1-7-42145-16 | In distribution | |
| 7-00001-31 | In distribution | |
| T-7-40044-68 | In distribution | |
| S1-7-42245-14 | In distribution | |
| 7-41145-18 | In distribution | |
| T-7-40043-67 | In distribution | |
| 7-42141-10 | In distribution | |
| S1-7-41141-10 | In distribution | |
| S1-7-00004-83 | In distribution | |
| 7-00003-47 | In distribution | |
| T-7-40044-88 | In distribution | |
| 700-430-16 | In distribution | |
| 7-00003-62 | In distribution | |
| T-7-40044-70 | In distribution | |
| S1-7-00002-44 | In distribution | |
| T-7-40041-22 | In distribution | |
| 700-412-40 | In distribution | |
| T-7-40042-39 | In distribution | |
| S1-7-00001-27 | In distribution | |
| 7-00004-84 | In distribution | |
| 7-00003-45 | In distribution | |
| S1-7-00002-47 | In distribution | |
| 7-00004-105 | In distribution | |
| T-7-40043-53 | In distribution | |
| 7-00001-24 | In distribution | |
| S1-7-00003-65 | In distribution | |
| 7-00003-55 | In distribution | |
| S1-7-41245-14 | In distribution | |
| 7-41241-16 | In distribution | |
| 900-430-30 | In distribution | |
| S1-7-00004-64 | In distribution | |
| S1-7-41245-10 | In distribution | |
| T-7-40044-64 | In distribution | |
| S1-7-00001-32 | In distribution | |
| 7-00001-19 | In distribution | |
| 900-430-40 | In distribution | |
| T-7-40044-59 | In distribution | |
| S1-7-00003-43 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K210286 | 2021-03-18 |
| K201136 | 2020-05-12 |
| K181543 | 2018-08-31 |
| K180090 | 2018-04-23 |
| K171538 | 2017-06-16 |
| K160604 | 2016-07-01 |
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.