Zavation
Custom T25 Torx Screwdriver Anterior / Lateral Plate
13manufacturers in China registered for this device type
864catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Zavation, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K211113 |
| Record published | 2021-10-05 |
| Record revised | 2025-02-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2019-02-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600-4560 | In distribution | |
| 13-C040 | In distribution | |
| 13-8530 | In distribution | |
| ZAV-1172-11 | In distribution | |
| 620-4570 | In distribution | |
| ZAV-1094 | In distribution | |
| ZAV-1123-18 | In distribution | |
| 12-8540 | In distribution | |
| 213-8555 | In distribution | |
| 630-4595 | In distribution | |
| 10-8595 | In distribution | |
| ZAV-1197-13 | In distribution | |
| 600-4550 | In distribution | |
| ZAV-1201 | In distribution | |
| 630-4535 | In distribution | |
| 213-7585 | In distribution | |
| 600-4595 | In distribution | |
| 11-S075 | In distribution | |
| 600-5590 | In distribution | |
| 630-6530 | In distribution | |
| 670-6530-1 | In distribution | |
| 630-5525 | In distribution | |
| 670-7570-1 | In distribution | |
| 673-8535-1 | In distribution | |
| 13-7580 | In distribution | |
| ZAV-1197-14 | In distribution | |
| 12-4540 | In distribution | |
| 630-4585 | In distribution | |
| ZAV-1279-10 | In distribution | |
| ZAV-1182-D08 | In distribution | |
| ZAV-1263D-14 | In distribution | |
| 10-6545 | In distribution | |
| ZAV-1194-S-13 | In distribution | |
| 13-C065 | In distribution | |
| ZAV-1174 | In distribution | |
| 630-7525 | In distribution | |
| 13-5535 | In distribution | |
| 10-7560 | In distribution | |
| ZAV-1232-15 | In distribution | |
| 670-8530-1 | In distribution | |
| 11-S095 | In distribution | |
| 13-4535 | In distribution | |
| 353-1010 | In distribution | |
| 600-5555 | In distribution | |
| ZAV-1263S-14 | In distribution | |
| 13-1005-45 | In distribution | |
| ZAV-1233 | In distribution | |
| 673-8560-1 | In distribution | |
| 630-7530 | In distribution | |
| 12-7590 | In distribution | |
| ZAV-1235 | In distribution | |
| ZAV-1212 | In distribution | |
| ZAV-1220 | In distribution | |
| 620-6540 | In distribution | |
| 670-6590-1 | In distribution | |
| 10-1035 | In distribution | |
| 600-5595 | In distribution | |
| 670-5560-1 | In distribution | |
| 620-4530 | In distribution | |
| 11-S300 | In distribution | |
| ZAV-1197-9 | In distribution | |
| 670-8545-1 | In distribution | |
| 213-8525 | In distribution | |
| 13-7575 | In distribution | |
| 13R-5545 | In distribution | |
| 13R-4560 | In distribution | |
| 13-1040 | In distribution | |
| 10-7545 | In distribution | |
| 670-5570-1 | In distribution | |
| 10-1008 | In distribution | |
| 620-5525 | In distribution | |
| 10-S170 | In distribution | |
| ZAV-1263S-08 | In distribution | |
| 630-5545 | In distribution | |
| ZAV-1182-S08 | In distribution | |
| ZAV-1134 | In distribution | |
| 620-6585 | In distribution | |
| 13-4550 | In distribution | |
| 670-7525-1 | In distribution | |
| 10-1021 | In distribution | |
| ZAV-1126 | In distribution | |
| 630-5500 | In distribution | |
| 13R-6595 | In distribution | |
| 10-8565 | In distribution | |
| 673-8550-1 | In distribution | |
| Z-1024 | In distribution | |
| ZAV-1202 | In distribution | |
| 673-6580-1 | In distribution | |
| ZAV-1115-5 | In distribution | |
| ZAV-1183 | In distribution | |
| 670-6555-1 | In distribution | |
| 10-C140 | In distribution | |
| 670-6550-1 | In distribution | |
| ZAV-1253-B | In distribution | |
| ZAV-1323 | In distribution | |
| 630-5550 | In distribution | |
| 600-8535 | In distribution | |
| 673-6545-1 | In distribution | |
| 13R-8560 | In distribution | |
| 630-6585 | In distribution | |
| 13-6580 | In distribution | |
| 670-8570-1 | In distribution | |
| 13-8555 | In distribution | |
| ZAV-1194-S-10 | In distribution | |
| 13-8575 | In distribution | |
| 620-5540 | In distribution | |
| 10-6580 | In distribution | |
| 620-7580 | In distribution | |
| 10-10 | In distribution | |
| ZAV-1182-S16 | In distribution | |
| 620-4560 | In distribution | |
| 673-6575-1 | In distribution | |
| 673-6570-1 | In distribution | |
| ZAV-1263S-16 | In distribution | |
| ZAV-1243 | In distribution | |
| 620-7585 | In distribution | |
| 620-5560 | In distribution | |
| 600-6555 | In distribution | |
| 620-7565 | In distribution | |
| 10-1025 | In distribution | |
| 13R-6555 | In distribution | |
| 670-5580-1 | In distribution | |
| 620-5545 | In distribution | |
| 670-5550-1 | In distribution | |
| 673-8565-1 | In distribution | |
| 670-4575-1 | In distribution | |
| 11-C050 | In distribution | |
| 600-6580 | In distribution | |
| ZAV-1238 | In distribution | |
| 10-80 | In distribution | |
| ZAV-1263S-11 | In distribution | |
| ZAV-1122-55 | In distribution | |
| 630-4550 | In distribution | |
| 670-7540-1 | In distribution | |
| 213-8575 | In distribution | |
| 10-S070 | In distribution | |
| 11-56 | In distribution | |
| ZAV-1115-21 | In distribution | |
| 673-4595-1 | In distribution | |
| ZAV-1309 | In distribution | |
| 620-6555 | In distribution | |
| 11-S080 | In distribution | |
| 670-8550-1 | In distribution | |
| ZAV-1194-D-15 | In distribution | |
| 10-S190 | In distribution | |
| 600-5570 | In distribution | |
| 630-7540 | In distribution | |
| 13-7555 | In distribution | |
| 620-6575 | In distribution | |
| 630-4525 | In distribution | |
| ZAV-1179-S | In distribution | |
| 630-7560 | In distribution | |
| 620-7525 | In distribution | |
| 10-1022-D | In distribution | |
| 670-4580-1 | In distribution | |
| ZAV-1098-65 | In distribution | |
| 10-S050 | In distribution | |
| 673-7525-1 | In distribution | |
| 600-5530 | In distribution | |
| 630-7550 | In distribution | |
| 600-4575 | In distribution | |
| 10-S055 | In distribution | |
| 620-7560 | In distribution | |
| ZAV-1279-09 | In distribution | |
| 10-C045 | In distribution | |
| 673-8575-1 | In distribution | |
| 12-7550 | In distribution | |
| ZAV-1345 | In distribution | |
| 673-4550-1 | In distribution | |
| 10-1048 | In distribution | |
| 10-4540 | In distribution | |
| 13-1044 | In distribution | |
| 10-8585 | In distribution | |
| 670-5565-1 | In distribution | |
| 620-6560 | In distribution | |
| 10-5545 | In distribution | |
| ZAV-1032 | In distribution | |
| 600-6595 | In distribution | |
| 673-7580-1 | In distribution | |
| 673-8555-1 | In distribution | |
| 670-8525-1 | In distribution | |
| 10-C075 | In distribution | |
| ZAV-1196 | In distribution | |
| 600-8550 | In distribution | |
| 673-7590-1 | In distribution | |
| ZAV-1249 | In distribution | |
| 10-6590 | In distribution | |
| 13-S045 | In distribution | |
| 630-5565 | In distribution | |
| ZAV-1263S-12 | In distribution | |
| ZAV-1245 | In distribution | |
| 670-8560-1 | In distribution | |
| 673-4575-1 | In distribution | |
| 673-7540-1 | In distribution | |
| 600-7555 | In distribution | |
| 600-6545 | In distribution | |
| ZAV-1107-55 | In distribution | |
| ZAV-1263S-13 | In distribution | |
| 620-6595 | In distribution | |
| 670-6535-1 | In distribution | |
| ZAV-1128 | In distribution | |
| ZAV-1232-11 | In distribution | |
| ZAV-1194-S-08 | In distribution | |
| 673-8585-1 | In distribution | |
| 10-9006 | In distribution | |
| ZAV-1224 | In distribution | |
| 12-6595 | In distribution | |
| 13R-8590 | In distribution | |
| 13-1035-4 | In distribution | |
| 620-5565 | In distribution | |
| 11-S160 | In distribution | |
| 673-6555-1 | In distribution | |
| 13R-4540 | In distribution | |
| 600-7575 | In distribution | |
| 673-7575-1 | In distribution | |
| 600-5580 | In distribution | |
| 13-4525 | In distribution | |
| 13-S190 | In distribution | |
| 13-7535 | In distribution | |
| 10-8540 | In distribution | |
| 10-S090 | In distribution | |
| 10-6560 | In distribution | |
| 600-6590 | In distribution | |
| 673-6585-1 | In distribution | |
| 600-7585 | In distribution | |
| 13-1039-10 | In distribution | |
| 10-S115 | In distribution | |
| 11-S120 | In distribution | |
| ZAV-1232-13 | In distribution | |
| 10-S250 | In distribution | |
| 10-C200 | In distribution | |
| 630-6545 | In distribution | |
| 10-S160 | In distribution | |
| 10-1022 | In distribution | |
| ZAV-1195 | In distribution | |
| ZAV-1289 | In distribution | |
| 600-7565 | In distribution | |
| 213-8595 | In distribution | |
| 620-5550 | In distribution | |
| 670-6595-1 | In distribution | |
| 673-7560-1 | In distribution | |
| 213-7530 | In distribution | |
| 630-6550 | In distribution | |
| 630-5575 | In distribution | |
| 670-7550-1 | In distribution | |
| ZAV-1263D-10 | In distribution | |
| ZAV-1276 | In distribution | |
| ZAV-1336-10 | In distribution | |
| ZAV-1250 | In distribution | |
| ZAV-1095 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
| Astra Spine System | Spinecraft LLC | 786 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112484 | 2011-11-22 |
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.