Cetra
4.0MM X 19MM Primary Semi-Constrained Self-Drilling Screw
14manufacturers in China registered for this device type
181catalogue numbers in this listing
1510(k) clearance
1recall
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 | Orthofix US LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K162638 |
| Record published | 2019-03-12 |
| Record revised | 2026-02-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19-3517 | In distribution | |
| 19-0372 | In distribution | |
| 19-7015 | In distribution | |
| 19-7516 | In distribution | |
| 19-4012 | In distribution | |
| 19-3000 | In distribution | |
| 19-4020 | In distribution | |
| 19-7511 | In distribution | |
| 19-8510 | In distribution | |
| 19-6019 | In distribution | |
| 19-8012 | In distribution | |
| 19-7011 | In distribution | |
| 19-0482 | In distribution | |
| 19-6013 | In distribution | |
| 19-0252 | In distribution | |
| 19-5520 | In distribution | |
| 19-0354 | In distribution | |
| 19-0370 | In distribution | |
| 19-7010 | In distribution | |
| 19-6017 | In distribution | |
| 19-0254 | In distribution | |
| 19-7019 | In distribution | |
| 19-5515 | In distribution | |
| 19-5518 | In distribution | |
| 19-0362 | In distribution | |
| 19-5514 | In distribution | |
| 19-3515 | In distribution | |
| 19-8514 | In distribution | |
| 19-8513 | In distribution | |
| 19-0494 | In distribution | |
| 19-5018 | In distribution | |
| 19-0124 | In distribution | |
| 19-0234 | In distribution | |
| 19-3013 | In distribution | |
| 19-6520 | In distribution | |
| 19-4013 | In distribution | |
| 19-6515 | In distribution | |
| 19-4019 | In distribution | |
| 19-7014 | In distribution | |
| 19-8018 | In distribution | |
| 19-6010 | In distribution | |
| 19-7510 | In distribution | |
| 19-7517 | In distribution | |
| 19-5512 | In distribution | |
| 19-0474 | In distribution | |
| 19-3019 | In distribution | |
| 19-0136 | In distribution | |
| 19-8013 | In distribution | |
| 19-0360 | In distribution | |
| 19-6516 | In distribution | |
| 19-0118 | In distribution | |
| 19-5513 | In distribution | |
| 19-0242 | In distribution | |
| 19-3018 | In distribution | |
| 19-7513 | In distribution | |
| 19-3016 | In distribution | |
| 19-5019 | In distribution | |
| 19-3518 | In distribution | |
| 19-0246 | In distribution | |
| 19-8515 | In distribution | |
| 19-8512 | In distribution | |
| 19-0236 | In distribution | |
| 19-4511 | In distribution | |
| 19-3011 | In distribution | |
| 19-8015 | In distribution | |
| 19-8019 | In distribution | |
| 19-3520 | In distribution | |
| 19-4514 | In distribution | |
| 19-4010 | In distribution | |
| 19-3511 | In distribution | |
| 19-4015 | In distribution | |
| 19-3017 | In distribution | |
| 19-0486 | In distribution | |
| 19-0244 | In distribution | |
| 19-5016 | In distribution | |
| 19-3010 | In distribution | |
| 19-5020 | In distribution | |
| 19-3014 | In distribution | |
| 19-0119 | In distribution | |
| 19-4016 | In distribution | |
| 19-5010 | In distribution | |
| 19-6519 | In distribution | |
| 19-4519 | In distribution | |
| 19-6518 | In distribution | |
| 19-6016 | In distribution | |
| 19-0120 | In distribution | |
| 19-0128 | In distribution | |
| 19-6012 | In distribution | |
| 19-8518 | In distribution | |
| 19-0462 | In distribution | |
| 19-6514 | In distribution | |
| 19-7016 | In distribution | |
| 19-8511 | In distribution | |
| 19-6015 | In distribution | |
| 19-0356 | In distribution | |
| 19-0366 | In distribution | |
| 19-5510 | In distribution | |
| 19-0248 | In distribution | |
| 19-8014 | In distribution | |
| 19-0250 | In distribution | |
| 19-4515 | In distribution | |
| 19-5516 | In distribution | |
| 19-3514 | In distribution | |
| 19-5017 | In distribution | |
| 19-7012 | In distribution | |
| 19-7512 | In distribution | |
| 19-0352 | In distribution | |
| 19-7018 | In distribution | |
| 19-5014 | In distribution | |
| 19-7518 | In distribution | |
| 19-5511 | In distribution | |
| 19-0132 | In distribution | |
| 19-4512 | In distribution | |
| 19-3020 | In distribution | |
| 19-6512 | In distribution | |
| 19-8020 | In distribution | |
| 19-8016 | In distribution | |
| 19-0232 | In distribution | |
| 19-8011 | In distribution | |
| 19-0117 | In distribution | |
| 19-7013 | In distribution | |
| 19-3519 | In distribution | |
| 19-4018 | In distribution | |
| 19-4516 | In distribution | |
| 19-0490 | In distribution | |
| 19-0358 | In distribution | |
| 19-4017 | In distribution | |
| 19-7020 | In distribution | |
| 19-8010 | In distribution | |
| 19-7017 | In distribution | |
| 19-6018 | In distribution | |
| 19-0116 | In distribution | |
| 19-3015 | In distribution | |
| 19-5013 | In distribution | |
| 19-0122 | In distribution | |
| 19-0350 | In distribution | |
| 19-8517 | In distribution | |
| 19-0348 | In distribution | |
| 19-0134 | In distribution | |
| 19-0368 | In distribution | |
| 19-5012 | In distribution | |
| 19-8516 | In distribution | |
| 19-4520 | In distribution | |
| 19-6510 | In distribution | |
| 19-0240 | In distribution | |
| 19-0130 | In distribution | |
| 19-4011 | In distribution | |
| 19-6517 | In distribution | |
| 19-5011 | In distribution | |
| 19-0470 | In distribution | |
| 19-6020 | In distribution | |
| 19-3510 | In distribution | |
| 19-0374 | In distribution | |
| 19-3512 | In distribution | |
| 19-7520 | In distribution | |
| 19-7514 | In distribution | |
| 19-8520 | In distribution | |
| 19-0238 | In distribution | |
| 19-8017 | In distribution | |
| 19-6511 | In distribution | |
| 19-6011 | In distribution | |
| 19-4014 | In distribution | |
| 19-0478 | In distribution | |
| 19-6014 | In distribution | |
| 19-3513 | In distribution | |
| 19-4517 | In distribution | |
| 19-7515 | In distribution | |
| 19-0466 | In distribution | |
| 19-4510 | In distribution | |
| 19-3012 | In distribution | |
| 19-5519 | In distribution | |
| 19-0364 | In distribution | |
| 19-5015 | In distribution | |
| 19-8519 | In distribution | |
| 19-7519 | In distribution | |
| 19-6513 | In distribution | |
| 19-3516 | In distribution | |
| 19-4513 | In distribution | |
| 19-5517 | In distribution | |
| 19-0126 | In distribution | |
| 19-4518 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211712 | 2022-02-11 |
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2013-10-29 | Class II | Component design/selection | There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. | 4,172 units | 2014-12-09 |
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.