Boundary
Buttress Plate Screw 30mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level…
Buttress Plate Screw 30mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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 | Nvision Biomedical Technologies, Inc, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K173091 |
| Record published | 2018-02-28 |
| Record revised | 2026-07-28 (version 8) |
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 |
| Storage | Special storage condition: A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Sizes | Length 15 to 35 mm; circumference 5.5 to 6 mm; angle 0 to 8 °; width 15 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AL-BUT-158 | Angle 8 ° | In distribution |
| ALB-55S-25 | Length 25 mm | In distribution |
| BUT-1000T-TAP | In distribution | |
| ALB-60L-35 | Circumference 6.0 mm | In distribution |
| AL-BUT-150 | Angle 0 ° | In distribution |
| ALB-60L-25 | Circumference 6.0 mm | In distribution |
| BUT-1000T-SREW | In distribution | |
| ALB-60L-20 | Length 20 mm | In distribution |
| ALB-60S-35 | Circumference 6.0 mm | In distribution |
| ALB-60S-20 | Length 20 mm | In distribution |
| ALB-55SC-30 | Circumference 5.5 mm | In distribution |
| BUT-1000T-PLTE | In distribution | |
| BUT-1000T-DRL | In distribution | |
| ALB-60L-30 | Length 30 mm | In distribution |
| ALB-55SC-35 | Length 35 mm | In distribution |
| ALB-55LC-20 | Circumference 5.5 mm | In distribution |
| ALB-60S-30 | Length 30 mm | In distribution |
| AL-BUT-258 | Width 15 mm | In distribution |
| AL-BUT-250 | Angle 0 ° | In distribution |
| ALB-55L-25 | Length 25 mm | In distribution |
| BUT-1000T-500 | In distribution | |
| AL-BUT-208 | Width 15 mm | In distribution |
| ALB-55L-35 | Circumference 5.5 mm | In distribution |
| ALB-55LC-25 | Length 25 mm | In distribution |
| ALB-55LC-35 | Circumference 5.5 mm | In distribution |
| ALB-55S-20 | Circumference 5.5 mm | In distribution |
| ALB-60S-25 | Circumference 6.0 mm | In distribution |
| AL-BUT-200 | Angle 0 ° | In distribution |
| ALB-55S-30 | Circumference 5.5 mm | In distribution |
| ALB-55S-35 | Length 35 mm | In distribution |
| ALB-55SC-25 | Length 25 mm | In distribution |
| ALB-55L-20 | Circumference 5.5 mm | In distribution |
| ALB-55SC-20 | Circumference 5.5 mm | In distribution |
| ALB-55L-30 | Length 30 mm | In distribution |
| ALB-55LC-30 | Length 30 mm | In distribution |
| BUT-1000T-AWL | 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 |
|---|---|
| K210424 | 2021-10-22 |
| K173091 | 2017-12-06 |
| K161524 | 2016-09-02 |
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.