Matrixx System
CIB Parallel Solid 14Dx16Wx11H
7manufacturers in China registered for this device type
95catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K171140 |
| Record published | 2018-09-20 |
| Record revised | 2023-04-04 (version 7) |
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 |
| Sizes | Height 5 to 18 mm; width 12 to 18 mm; angle 0 to 10 °; length 12 to 16 mm; depth 12 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50M-1618-10-SP | Height 10 mm | In distribution |
| 51M-1214-10-06-SP | Angle 10 ° | In distribution |
| 50A-1618-09-SP | Width 18 mm | In distribution |
| 51M-1416-10-07-SP | Angle 10 ° | In distribution |
| 50A-1416-05-SP | Width 16 mm | In distribution |
| 51M-1214-10-08-SP | Angle 10 ° | In distribution |
| 50A-1214-07-SP | Width 14 mm | In distribution |
| C50-01-01 | In distribution | |
| 50M-1214-08-SP | Height 8 mm | In distribution |
| 50M-1416-08-SP | Length 14 mm | In distribution |
| 50M-1618-08-SP | Height 8 mm | In distribution |
| 51M-1416P-11-SP | Angle 0 ° | In distribution |
| 50M-1416P-14-SP | Angle 0 ° | In distribution |
| 51M-1214-10-12-SP | Angle 10 ° | In distribution |
| 50A-1618-10-SP | Width 18 mm | In distribution |
| 51M-1214-10-09-SP | Angle 10 ° | In distribution |
| 50M-1214-10-SP | Height 10 mm | In distribution |
| 50M-1214P-05-SP | Angle 0 ° | In distribution |
| 50M-1618-14-SP | Height 14 mm | In distribution |
| 51M-1618-10-08-SP | Angle 10 ° | In distribution |
| 51M-1618-10-07-SP | Angle 10 ° | In distribution |
| 50M-1416-10-SP | Length 14 mm | In distribution |
| 50A-1214-06-SP | Width 14 mm | In distribution |
| 51M-1214-10-11-SP | Angle 10 ° | In distribution |
| 51M-1214P-16-SP | Angle 0 ° | In distribution |
| 50M-1214P-11-SP | Angle 0 ° | In distribution |
| 51M-1618-10-12-SP | Angle 10 ° | In distribution |
| 51M-1416-10-08-SP | Angle 10 ° | In distribution |
| 50A-1618-06-SP | Width 18 mm | In distribution |
| 50M-1416P-06-SP | Angle 0 ° | In distribution |
| 50M-1618-15-SP | Height 15 mm | In distribution |
| 50A-1214-08-SP | Width 14 mm | In distribution |
| 50A-1416-07-SP | Width 16 mm | In distribution |
| 50A-1214-10-SP | Width 14 mm | In distribution |
| 51M-1214P-12-SP | Angle 0 ° | In distribution |
| 51M-1214-10-10-SP | Angle 10 ° | In distribution |
| 51M-1416P-09-SP | Angle 0 ° | In distribution |
| 50A-1416-09-SP | Width 16 mm | In distribution |
| 51M-1214P-15-SP | Angle 0 ° | In distribution |
| 50M-1416P-10-SP | Angle 0 ° | In distribution |
| 50M-1214-06-SP | Height 6 mm | In distribution |
| 51M-1618-10-10-SP | Angle 10 ° | In distribution |
| 51M-1416P-13-SP | Angle 0 ° | In distribution |
| 51M-1416-10-10-SP | Angle 10 ° | In distribution |
| 50M-1214P-07-SP | Angle 0 ° | In distribution |
| 50M-1214-14-SP | Height 14 mm | In distribution |
| 50A-1416-11-SP | Width 16 mm | In distribution |
| 50A-1416-06-SP | Width 16 mm | In distribution |
| 50A-1416-10-SP | Width 16 mm | In distribution |
| 50M-1416-07-SP | Height 7 mm | In distribution |
| 50A-1618-08-SP | Width 18 mm | In distribution |
| 50M-1618-11-SP | Height 11 mm | In distribution |
| 51M-1214P-14-SP | Angle 0 ° | In distribution |
| 50M-1214P-13-SP | Angle 0 ° | In distribution |
| 50M-1214-12-SP | Height 12 mm | In distribution |
| 50A-1618-11-SP | Width 18 mm | In distribution |
| 50M-1416P-08-SP | Angle 0 ° | In distribution |
| 51M-1416-10-06-SP | Angle 10 ° | In distribution |
| 50M-1212-05-SP | Height 5 mm | In distribution |
| 51M-1618-10-06-SP | Angle 10 ° | In distribution |
| 51M-1618-10-11-SP | Angle 10 ° | In distribution |
| 50A-1618-12-SP | Width 18 mm | In distribution |
| 51M-1416-10-12-SP | Angle 10 ° | In distribution |
| 50M-1618-18-SP | Height 18 mm | In distribution |
| 50M-1618-12-SP | Height 12 mm | In distribution |
| 50A-1416-08-SP | Width 16 mm | In distribution |
| 51M-1618-10-09-SP | Angle 10 ° | In distribution |
| 50M-1618-06-SP | Height 6 mm | In distribution |
| 50M-1618-13-SP | Height 13 mm | In distribution |
| 51M-1214P-17-SP | Angle 0 ° | In distribution |
| 50A-1214-09-SP | Width 14 mm | In distribution |
| 51M-1416P-07-SP | Angle 0 ° | In distribution |
| 50M-1416P-18-SP | Angle 0 ° | In distribution |
| 51M-1416-10-09-SP | Angle 10 ° | In distribution |
| 50M-1416P-17-SP | Angle 0 ° | In distribution |
| 51M-1214-10-07-SP | Angle 10 ° | In distribution |
| 50M-1416P-12-SP | Angle 0 ° | In distribution |
| 51M-1214P-08-SP | Angle 0 ° | In distribution |
| 51M-1416P-05-SP | Angle 0 ° | In distribution |
| 50M-1416P-15-SP | Angle 0 ° | In distribution |
| 50A-1214-05-SP | Width 14 mm | In distribution |
| 50A-1416-12-SP | Width 16 mm | In distribution |
| 50M-1214P-09-SP | Angle 0 ° | In distribution |
| 50M-1416-05-SP | Height 5 mm | In distribution |
| 50M-1416P-16-SP | Angle 0 ° | In distribution |
| 50A-1618-05-SP | Width 18 mm | In distribution |
| 51M-1214P-10-SP | Angle 0 ° | In distribution |
| 51M-1214P-18-SP | Angle 0 ° | In distribution |
| 50A-1214-12-SP | Width 14 mm | In distribution |
| 50A-1214-11-SP | Width 14 mm | In distribution |
| 50M-1618-17-SP | Height 17 mm | In distribution |
| 51M-1214P-06-SP | Angle 0 ° | In distribution |
| 50M-1618-16-SP | Height 16 mm | In distribution |
| 51M-1416-10-11-SP | Angle 10 ° | In distribution |
| 50A-1618-07-SP | Width 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171140 | 2017-08-22 |
| K120345 | 2012-06-13 |
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.