Aspen MIS Fusion System
PLATE-POST BODY, FLARED, Ti 16MM
11manufacturers in China registered for this device type
52catalogue numbers in this listing
2recalls on this code
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 | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-12-29 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6252-0016-003 | In distribution | |
| 6262-0108-003 | Device Size Text, specify—PLATE-POST BODY MEDIUM TI 30MM | In distribution |
| 6251-0014-001 | In distribution | |
| 6262-1108-003 | Device Size Text, specify—PLATE-POST BODY MEDIUM TI 35MM | In distribution |
| 6212-0014 | In distribution | |
| 6261-0108-003 | Device Size Text, specify—PLATE-POST BODY WIDE TI 30MM | In distribution |
| 6261-0108-001 | Device Size Text, specify—LOCK-PLATE TI 30MM | In distribution |
| 6201-0001-002 | In distribution | |
| 6251-0014-003 | In distribution | |
| 6251-0018-001 | In distribution | |
| 6211-1006-003 | In distribution | |
| 6211-0016-003 | In distribution | |
| 6261-2108-003 | Device Size Text, specify—PLATE-POST BODY WIDE TI 45MM | In distribution |
| 6211-0014-003 | In distribution | |
| 6252-0018-003 | In distribution | |
| 6261-2108-001 | Device Size Text, specify—LOCK-PLATE TI 45MM | In distribution |
| 6212-0016 | In distribution | |
| 6201-1006-001 | In distribution | |
| 6211-0018-003 | In distribution | |
| 6261-0105-003 | Device Size Text, specify—PLATE POST WIDE TI 26MM | In distribution |
| 6201-1010-001 | In distribution | |
| 6201-0016-001 | In distribution | |
| 6212-0014-003 | In distribution | |
| 6201-1008-001 | In distribution | |
| 6212-0010 | In distribution | |
| 6261-0105-001 | Device Size Text, specify—LOCK PLATE TI 26MM | In distribution |
| 6211-1010-003 | In distribution | |
| 6262-3108-003 | Device Size Text, specify—PLATE-POST BODY MEDIUM TI 55MM | In distribution |
| 6251-0016-001 | In distribution | |
| 6201-0018-001 | In distribution | |
| 6263-0108-003 | Device Size Text, specify—PLATE-POST BODY NARROW TI 30MM | In distribution |
| 6261-1108-001 | Device Size Text, specify—LOCK-PLATE TI 35MM | In distribution |
| 6263-3108-003 | Device Size Text, specify—PLATE-POST BODY NARROW TI 55MM | In distribution |
| 6211-1008-003 | In distribution | |
| 6212-0006 | In distribution | |
| 6251-0016-003 | In distribution | |
| 6211-1012-003 | In distribution | |
| 6212-0012 | In distribution | |
| 6212-0016-003 | In distribution | |
| 6261-3108-003 | Device Size Text, specify—PLATE-POST BODY WIDE TI 55MM | In distribution |
| 6212-0018-003 | In distribution | |
| 6212-0018 | In distribution | |
| 6201-0014-001 | In distribution | |
| 6261-1108-003 | Device Size Text, specify—PLATE-POST BODY WIDE TI 35MM | In distribution |
| 6263-1108-003 | Device Size Text, specify—PLATE-POST BODY NARROW TI 35MM | In distribution |
| 6262-2108-003 | Device Size Text, specify—PLATE-POST BODY MEDIUM TI 45MM | In distribution |
| 6212-0008 | In distribution | |
| 6201-1012-001 | In distribution | |
| 6263-2108-003 | Device Size Text, specify—PLATE-POST BODY NARROW TI 45MM | In distribution |
| 6252-0014-003 | In distribution | |
| 6261-3108-001 | Device Size Text, specify—LOCK-PLATE TI 55MM | In distribution |
| 6251-0018-003 | In distribution |
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
Recalls
2 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 |
| 2015-07-22 | Class II | Device Design | Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities. | 49 | 2015-12-10 |
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.