Zavation
Polyaxial Screwdriver, 2.5mm straight hex - small handle
11manufacturers in China registered for this device type
532catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Zavation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K162575 |
| Record published | 2022-04-05 |
| Record revised | 2025-02-06 (version 6) |
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 | 2018-01-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 93-4036 | In distribution | |
| 92-3548 | In distribution | |
| 92-3534 | In distribution | |
| 95-5014 | In distribution | |
| 13-1039-19 | In distribution | |
| 11-S180 | In distribution | |
| 12-7530 | In distribution | |
| 13R-8530 | In distribution | |
| 95-4050 | In distribution | |
| 10-1005-65 | In distribution | |
| 95-4538 | In distribution | |
| ZAV-1073 | In distribution | |
| 93-5014 | In distribution | |
| 99-1029 | In distribution | |
| 93-4014 | In distribution | |
| 95-4022 | In distribution | |
| 93-5042 | In distribution | |
| ZAV-1041 | In distribution | |
| 12-4525 | In distribution | |
| ZAV-1108 | In distribution | |
| 93-5012 | In distribution | |
| 12-7540 | In distribution | |
| 13R-7530 | In distribution | |
| 98-34 | In distribution | |
| 10-1019 | In distribution | |
| 11-S110 | In distribution | |
| 10-6550 | In distribution | |
| 99-1034 | In distribution | |
| 99-1015 | In distribution | |
| 13-S070 | In distribution | |
| 96-C040 | In distribution | |
| 13-1053 | In distribution | |
| 97-3520 | In distribution | |
| 11-35 | In distribution | |
| 93-3518 | In distribution | |
| 12-5530 | In distribution | |
| 93-4032 | In distribution | |
| 93-4528 | In distribution | |
| 13R-8585 | In distribution | |
| 11-C085 | In distribution | |
| 94-31-55-55 | In distribution | |
| 99-1002 | In distribution | |
| 93-5016 | In distribution | |
| 10-1014 | In distribution | |
| 96-C080 | In distribution | |
| 10-1005-85 | In distribution | |
| 13-1047-75 | In distribution | |
| 95-5042 | In distribution | |
| 93-3548 | In distribution | |
| 95-5034 | In distribution | |
| 13-S055 | In distribution | |
| ZAV-1117 | In distribution | |
| 93-3528 | In distribution | |
| 11-S150 | In distribution | |
| 11-C075 | In distribution | |
| 93-5032 | In distribution | |
| 95-5044 | In distribution | |
| 99-1027 | In distribution | |
| 92-4020 | In distribution | |
| 12-6550 | In distribution | |
| 12-6590 | In distribution | |
| 10-1044 | In distribution | |
| 95-3518 | In distribution | |
| 13-65100 | In distribution | |
| ZAV-1014-2 | In distribution | |
| 97-3536 | In distribution | |
| 10-6565 | In distribution | |
| 97-3544 | In distribution | |
| 10-7530 | In distribution | |
| 93-4534 | In distribution | |
| 13-7550 | In distribution | |
| 92-3524 | In distribution | |
| 13R-4555 | In distribution | |
| ZAV-1115-9 | In distribution | |
| 12-8585 | In distribution | |
| 10-S060 | In distribution | |
| 13-6595 | In distribution | |
| 11-S070 | In distribution | |
| 10-S200 | In distribution | |
| 96-C100 | In distribution | |
| 10-1047 | In distribution | |
| 10-S100 | In distribution | |
| 97-4028 | In distribution | |
| 95-4034 | In distribution | |
| 93-5022 | In distribution | |
| 10-56 | In distribution | |
| 93-3510 | In distribution | |
| 95-3528 | In distribution | |
| ZAV-1127 | In distribution | |
| 93-5020 | In distribution | |
| 10-1040 | In distribution | |
| 12-5540 | In distribution | |
| Z-1008-MT | In distribution | |
| 13-7585 | In distribution | |
| 10-C060 | In distribution | |
| ZAV-1322 | In distribution | |
| 10-38 | In distribution | |
| 99-1008-14 | In distribution | |
| 10-1036 | In distribution | |
| 93-3544 | In distribution | |
| 93-4048 | In distribution | |
| 96-T240 | In distribution | |
| 96-T100 | In distribution | |
| 11-S500 | In distribution | |
| 13-C070 | In distribution | |
| 95-4550 | In distribution | |
| 99-1021 | In distribution | |
| 10-7575 | In distribution | |
| 93-4536 | In distribution | |
| 12-4545 | In distribution | |
| 13R-75100 | In distribution | |
| 95-4046 | In distribution | |
| 13-C085 | In distribution | |
| 13R-5555 | In distribution | |
| 95-3512 | In distribution | |
| 93-3526 | In distribution | |
| 13-S095 | In distribution | |
| 13-6575 | In distribution | |
| ZAV-1114 | In distribution | |
| ZAV-1339 | In distribution | |
| 10-33 | In distribution | |
| 94-31P-55-55 | In distribution | |
| 13-1005-55 | In distribution | |
| 10-6555 | In distribution | |
| 96-S060 | In distribution | |
| 13-6570 | In distribution | |
| ZAV-1093 | In distribution | |
| 13-1038 | In distribution | |
| 93-5052 | In distribution | |
| 95-5032 | In distribution | |
| 93-4526 | In distribution | |
| 11-S250 | In distribution | |
| ZAV-1291-40 | In distribution | |
| 12-4535 | In distribution | |
| 13-S200 | In distribution | |
| ZAV-1121 | In distribution | |
| 11-C120 | In distribution | |
| 13R-6570 | In distribution | |
| 13R-4545 | In distribution | |
| 13-9020 | In distribution | |
| 13-5530 | In distribution | |
| 13-1048-2 | In distribution | |
| 13-S075 | In distribution | |
| 95-3540 | In distribution | |
| 13-4545 | In distribution | |
| 10-1005-45 | In distribution | |
| 93-4514 | In distribution | |
| 93-3524 | In distribution | |
| 12-8575 | In distribution | |
| 10-1023-H | In distribution | |
| ZAV-1098-75 | In distribution | |
| 10-C130 | In distribution | |
| 93-5028 | In distribution | |
| 11-C035 | In distribution | |
| 92-3550 | In distribution | |
| ZAV-1104 | In distribution | |
| 11-S090 | In distribution | |
| 13R-8540 | In distribution | |
| 95-3552 | In distribution | |
| 95-4522 | In distribution | |
| 10-8560 | In distribution | |
| 96-C060 | In distribution | |
| 99-1009-25 | In distribution | |
| 13-8550 | In distribution | |
| 97-4036 | In distribution | |
| 13-1035-1 | In distribution | |
| 13R-7540 | In distribution | |
| 93-4010 | In distribution | |
| 93-5026 | In distribution | |
| 95-3532 | In distribution | |
| 11-10 | In distribution | |
| 96-T060 | In distribution | |
| 12-5555 | In distribution | |
| 10-4555 | In distribution | |
| 13R-5565 | In distribution | |
| 92-3540 | In distribution | |
| 12-8595 | In distribution | |
| 10-S130 | In distribution | |
| 10-C090 | In distribution | |
| 94-31-35-45 | In distribution | |
| 93-4544 | In distribution | |
| 13R-7590 | In distribution | |
| 13R-5530 | In distribution | |
| 93-4552 | In distribution | |
| 94-1060-S | In distribution | |
| 10-S300 | In distribution | |
| ZAV-1086 | In distribution | |
| 93-4524 | In distribution | |
| 11-S450 | In distribution | |
| 10-S400 | In distribution | |
| 10-C110 | In distribution | |
| 95-3516 | In distribution | |
| 95-3544 | In distribution | |
| 95-4018 | In distribution | |
| ZAV-1131 | In distribution | |
| ZAV-1137-S | In distribution | |
| 96-S040 | In distribution | |
| 11-C045 | In distribution | |
| 93-4042 | In distribution | |
| 93-3532 | In distribution | |
| 93-3520 | In distribution | |
| ZAV-1135 | In distribution | |
| 95-4542 | In distribution | |
| 11-S350 | In distribution | |
| Z-1008-GA | In distribution | |
| ZAV-1097 | In distribution | |
| 13-8585 | In distribution | |
| 11-S065 | In distribution | |
| 13R-85100 | In distribution | |
| 13-S050 | In distribution | |
| ZAV-1107-45 | In distribution | |
| 93-4050 | In distribution | |
| 10-4565 | In distribution | |
| 13-5550 | In distribution | |
| 93-3540 | In distribution | |
| 93-3538 | In distribution | |
| 95-5040 | In distribution | |
| ZAV-1320 | In distribution | |
| 93-4040 | In distribution | |
| 12-6545 | In distribution | |
| 10-8525 | In distribution | |
| 93-4546 | In distribution | |
| 13R-6560 | In distribution | |
| 10-S080 | In distribution | |
| 93-5050 | In distribution | |
| 95-5036 | In distribution | |
| 12-7585 | In distribution | |
| 12-7565 | In distribution | |
| ZAV-1268 | In distribution | |
| 13-S350 | In distribution | |
| 10-S045 | In distribution | |
| 92-3542 | In distribution | |
| 13-S035 | In distribution | |
| ZAV-1079 | In distribution | |
| 13R-7580 | In distribution | |
| 97-3524 | In distribution | |
| 93-4522 | In distribution | |
| 10-6595 | In distribution | |
| 95-4038 | In distribution | |
| 93-4538 | In distribution | |
| 95-4042 | In distribution | |
| 13R-7550 | In distribution | |
| 97-4024 | In distribution | |
| 93-5030 | In distribution | |
| 93-4520 | In distribution | |
| 99-1001-S | In distribution | |
| 10-1010 | In distribution | |
| ZAV-1122-65 | In distribution | |
| 13R-7560 | In distribution | |
| ZAV-1291-30 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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.