Ambassador
Ambassador,fixation PIN,TEMPORARY,2.3
14manufacturers in China registered for this device type
152catalogue numbers in this listing
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 | Choice Spine, LP |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K143576 |
| Record published | 2016-03-24 |
| Record revised | 2024-09-11 (version 7) |
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 |
| Sizes | Length 10 to 105 mm; outer diameter 4 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05-100-08-4010 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4512 | Length 12 mm | In distribution |
| 05-100-01-0010 | one level | In distribution |
| 05-100-09-4520 | Length 20 mm | In distribution |
| 05-100-08-4511 | Outer Diameter 4.5 mm | In distribution |
| 05-100-01-0020 | Length 20 mm | In distribution |
| 05-100-02-0026 | Length 26 mm | In distribution |
| 05-100-09-4522 | Length 22 mm | In distribution |
| 05-100-08-4513 | Outer Diameter 4.5 mm | In distribution |
| 05-100-10-4017 | Length 17 mm | In distribution |
| 05-100-03-0057 | Length 56 mm | In distribution |
| 05-100-08-4516 | Length 16 mm | In distribution |
| 05-100-03-0045 | Length 44 mm | In distribution |
| 05-100-10-4512 | Outer Diameter 4.5 mm | In distribution |
| 05-100-07-4517 | Outer Diameter 4.5 mm | In distribution |
| 05-100-10-4010 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4510 | Length 10 mm | In distribution |
| 05-100-10-4013 | Length 13 mm | In distribution |
| 05-100-10-4016 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4017 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4519 | Outer Diameter 4.5 mm | In distribution |
| 05-100-10-4520 | Outer Diameter 4.5 mm | In distribution |
| 05-100-07-4013 | Outer Diameter 4.0 mm | In distribution |
| 05-100-01-0012 | Length 12 mm | In distribution |
| 05-100-09-4514 | Length 14 mm | In distribution |
| 05-100-07-4014 | Length 14 mm | In distribution |
| 05-100-09-4013 | Length 13 mm | In distribution |
| 05-100-05-0095 | five levels | In distribution |
| 05-100-09-4513 | Outer Diameter 4.5 mm | In distribution |
| 05-100-01-0022 | one level | In distribution |
| 05-100-10-4018 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4520 | Length 20 mm | In distribution |
| 05-100-10-4014 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4018 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4016 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4516 | Length 16 mm | In distribution |
| 05-100-08-4011 | Length 11 mm | In distribution |
| 05-100-02-0038 | two levels | In distribution |
| 05-100-04-0072 | Length 72 mm | In distribution |
| 05-100-08-4519 | Outer Diameter 4.5 mm | In distribution |
| 05-100-10-4511 | Length 11 mm | In distribution |
| 05-100-07-4522 | Length 22 mm | In distribution |
| 05-100-07-4521 | Outer Diameter 4.5 mm | In distribution |
| 05-100-07-4011 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4010 | Length 10 mm | In distribution |
| 05-100-10-4021 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4517 | Outer Diameter 4.5 mm | In distribution |
| 05-100-08-4520 | Length 20 mm | In distribution |
| 05-109-18-0023 | In distribution | |
| 05-100-01-0026 | one level | In distribution |
| 05-100-03-0060 | three levels | In distribution |
| 05-100-01-0024 | Length 24 mm | In distribution |
| 05-100-10-4522 | Outer Diameter 4.5 mm | In distribution |
| 05-100-08-4510 | Length 10 mm | In distribution |
| 05-100-09-4516 | Length 16 mm | In distribution |
| 05-100-07-4519 | Outer Diameter 4.5 mm | In distribution |
| 05-100-05-0100 | Length 100 mm | In distribution |
| 05-100-10-4514 | Outer Diameter 4.5 mm | In distribution |
| 05-100-01-0014 | one level | In distribution |
| 05-100-08-4021 | Length 21 mm | In distribution |
| 05-100-07-4513 | Outer Diameter 4.5 mm | In distribution |
| 05-100-04-0080 | Length 80 mm | In distribution |
| 05-100-02-0028 | Length 28 mm | In distribution |
| 05-100-07-4518 | Length 18 mm | In distribution |
| 05-100-09-4020 | Outer Diameter 4.0 mm | In distribution |
| 05-100-10-4517 | Length 17 mm | In distribution |
| 05-100-08-4018 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4021 | Length 21 mm | In distribution |
| 05-100-07-4022 | Outer Diameter 4.0 mm | In distribution |
| 05-100-04-0056 | Length 56 mm | In distribution |
| 05-100-07-4515 | Outer Diameter 4.5 mm | In distribution |
| 05-100-08-4515 | Outer Diameter 4.5 mm | In distribution |
| 05-100-02-0036 | Length 36 mm | In distribution |
| 05-100-01-0028 | Length 28 mm | In distribution |
| 05-100-07-4511 | Outer Diameter 4.5 mm | In distribution |
| 05-100-09-4518 | Length 18 mm | In distribution |
| 05-100-04-0076 | four levels | In distribution |
| 05-100-04-0068 | four levels | In distribution |
| 05-100-08-4013 | Length 13 mm | In distribution |
| 05-100-05-0080 | Length 80 mm | In distribution |
| 05-100-09-4521 | Outer Diameter 4.5 mm | In distribution |
| 05-100-03-0054 | three levels | In distribution |
| 05-100-09-4512 | Length 12 mm | In distribution |
| 05-100-03-0051 | Length 50 mm | In distribution |
| 05-100-10-4519 | Length 19 mm | In distribution |
| 05-100-08-4019 | Length 19 mm | In distribution |
| 05-100-08-4512 | Length 12 mm | In distribution |
| 05-100-01-0016 | Length 16 mm | In distribution |
| 05-100-05-0105 | five levels | In distribution |
| 05-100-05-0085 | five levels | In distribution |
| 05-100-09-4010 | Outer Diameter 4.0 mm | In distribution |
| 05-100-10-4513 | Length 13 mm | In distribution |
| 05-100-08-4015 | Length 15 mm | In distribution |
| 05-100-02-0034 | two levels | In distribution |
| 05-100-03-0048 | three levels | In distribution |
| 05-100-09-4510 | Length 10 mm | In distribution |
| 05-100-10-4015 | Length 15 mm | In distribution |
| 05-100-08-4020 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4012 | Outer Diameter 4.0 mm | In distribution |
| 05-100-02-0044 | Length 44 mm | In distribution |
| 05-100-09-4022 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4017 | Length 17 mm | In distribution |
| 05-100-10-4012 | Outer Diameter 4.0 mm | In distribution |
| 05-100-04-0060 | four levels | In distribution |
| 05-100-01-0030 | one level | In distribution |
| 05-100-08-4522 | Length 22 mm | In distribution |
| 05-100-03-0042 | three levels | In distribution |
| 05-100-09-4019 | Length 19 mm | In distribution |
| 05-100-09-4015 | Length 15 mm | In distribution |
| 05-100-08-4012 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4015 | Outer Diameter 4.0 mm | In distribution |
| 05-100-03-0066 | three levels | In distribution |
| 05-100-08-4521 | Outer Diameter 4.5 mm | In distribution |
| 05-100-09-4014 | Outer Diameter 4.0 mm | In distribution |
| 05-100-07-4020 | Outer Diameter 4.0 mm | In distribution |
| 05-100-09-4515 | Outer Diameter 4.5 mm | In distribution |
| 05-100-10-4510 | Outer Diameter 4.5 mm | In distribution |
| 05-100-03-0063 | Length 62 mm | In distribution |
| 05-100-08-4514 | Length 14 mm | In distribution |
| 05-100-10-4521 | Length 21 mm | In distribution |
| 05-100-04-0088 | Length 88 mm | In distribution |
| 05-100-02-0024 | Length 24 mm | In distribution |
| 05-100-02-0032 | Length 32 mm | In distribution |
| 05-100-08-4518 | Length 18 mm | In distribution |
| 05-100-07-4514 | Length 14 mm | In distribution |
| 05-100-10-4515 | Length 15 mm | In distribution |
| 05-100-02-0042 | two levels | In distribution |
| 05-100-10-4516 | Outer Diameter 4.5 mm | In distribution |
| 05-100-08-4014 | Outer Diameter 4.0 mm | In distribution |
| 05-100-10-4022 | Length 22 mm | In distribution |
| 05-100-07-4012 | Length 12 mm | In distribution |
| 05-100-07-4016 | Length 16 mm | In distribution |
| 05-100-08-4517 | Outer Diameter 4.5 mm | In distribution |
| 05-100-10-4011 | Length 11 mm | In distribution |
| 05-100-08-4017 | Length 17 mm | In distribution |
| 05-100-07-4021 | Length 21 mm | In distribution |
| 05-100-10-4518 | Outer Diameter 4.5 mm | In distribution |
| 05-100-02-0030 | two levels | In distribution |
| 05-100-08-4016 | Outer Diameter 4.0 mm | In distribution |
| 05-100-04-0064 | Length 64 mm | In distribution |
| 05-100-10-4019 | Length 19 mm | In distribution |
| 05-100-07-4018 | Outer Diameter 4.0 mm | In distribution |
| 05-100-08-4022 | Outer Diameter 4.0 mm | In distribution |
| 05-100-10-4020 | Length 20 mm | In distribution |
| 05-100-07-4019 | Length 19 mm | In distribution |
| 05-100-09-4011 | Length 11 mm | In distribution |
| 05-100-01-0018 | one level | In distribution |
| 05-100-09-4511 | Outer Diameter 4.5 mm | In distribution |
| 05-100-05-0075 | five levels | In distribution |
| 05-100-05-0090 | Length 90 mm | In distribution |
| 05-100-02-0040 | Length 40 mm | In distribution |
| 05-100-04-0084 | four levels | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2015-05-21 | Class II | Release of Material/Component prior to receiving test results | Shipped to a single consignee prior to completion of final inspection. | 2 devices. | 2015-07-16 |
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.