48mm Anterior Sacral Plate
Catalogue number 25-SP-48, listed by Pioneer Surgical Technology, Inc., 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
1catalogue number
12510(k) clearances naming this product code
40recalls 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 | Pioneer Surgical Technology, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2015-11-06 |
| Record revised | 2026-02-16 (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 |
| Distribution end date | 2023-05-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-SP-48 | Withdrawn |
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 |
|---|---|
| K251436 | 2025-07-11 |
| K222493 | 2022-11-18 |
| K211408 | 2021-06-23 |
| K130427 | 2013-06-05 |
| K120724 | 2012-05-07 |
| K111528 | 2011-08-24 |
| K100708 | 2010-06-04 |
| K090222 | 2009-04-28 |
| K083663 | 2009-02-25 |
| K072703 | 2008-01-10 |
| K053053 | 2005-11-16 |
| K043066 | 2005-02-03 |
Recalls
40 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 |
|---|---|---|---|---|
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | 65 units |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision |
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.