Cequence
Semi-Constrained Rescue Screw, self-tapping
14manufacturers in China registered for this device type
115catalogue numbers in this listing
12510(k) clearances naming this product code
40recalls on this code
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 | Pioneer Surgical Technology, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2015-12-08 |
| Record revised | 2026-02-16 (version 8) |
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 110 mm |
| Distribution end date | 2023-05-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0203-0021 | Length 63 mm | Withdrawn |
| 0211-0018 | Length 18 mm | Withdrawn |
| 0217-4516 | Length 16 mm | Withdrawn |
| 0202-0016 | Length 32 mm | Withdrawn |
| 0203-0015 | Length 45 mm | Withdrawn |
| 0215-0021 | Length 105 mm | Withdrawn |
| 0206-4016 | Length 16 mm | Withdrawn |
| 0206-4014 | Length 14 mm | Withdrawn |
| 0201-0024 | Length 24 mm | Withdrawn |
| 0215-0020 | Length 100 mm | Withdrawn |
| 0211-0014 | Length 14 mm | Withdrawn |
| 0214-0022 | Length 88 mm | Withdrawn |
| 0214-0021 | Length 84 mm | Withdrawn |
| 0215-0014 | Length 70 mm | Withdrawn |
| 0202-0022 | Length 44 mm | Withdrawn |
| 0203-0022 | Length 66 mm | Withdrawn |
| 0207-4516 | Length 16 mm | Withdrawn |
| 0211-0020 | Length 20 mm | Withdrawn |
| 0202-0017 | Length 34 mm | Withdrawn |
| 0207-4518 | Length 18 mm | Withdrawn |
| 0213-0014 | Length 42 mm | Withdrawn |
| 0203-0019 | Length 57 mm | Withdrawn |
| 0205-0018 | Length 90 mm | Withdrawn |
| 0211-0012 | Length 12 mm | Withdrawn |
| 0212-0017 | Length 34 mm | Withdrawn |
| 0201-0010 | Length 10 mm | Withdrawn |
| 0202-0018 | Length 36 mm | Withdrawn |
| 0203-0014 | Length 42 mm | Withdrawn |
| 0203-0020 | Length 60 mm | Withdrawn |
| 0217-4518 | Length 18 mm | Withdrawn |
| 0211-0016 | Length 16 mm | Withdrawn |
| 0211-0026 | Length 26 mm | Withdrawn |
| 0212-0019 | Length 38 mm | Withdrawn |
| 0207-4012 | Length 12 mm | Withdrawn |
| 0211-0022 | Length 22 mm | Withdrawn |
| 0207-4014 | Length 14 mm | Withdrawn |
| 0215-0016 | Length 80 mm | Withdrawn |
| 0216-4018 | Length 18 mm | Withdrawn |
| 0205-0021 | Length 105 mm | Withdrawn |
| 0201-0022 | Length 22 mm | Withdrawn |
| 0201-0012 | Length 12 mm | Withdrawn |
| 0205-0017 | Length 85 mm | Withdrawn |
| 0213-0021 | Length 63 mm | Withdrawn |
| 0214-0019 | Length 76 mm | Withdrawn |
| 0212-0022 | Length 44 mm | Withdrawn |
| 0211-0010 | Length 10 mm | Withdrawn |
| 0213-0016 | Length 48 mm | Withdrawn |
| 0214-0015 | Length 60 mm | Withdrawn |
| 0201-0016 | Length 16 mm | Withdrawn |
| 0213-0022 | Length 66 mm | Withdrawn |
| 0217-4514 | Length 14 mm | Withdrawn |
| 0203-0017 | Length 51 mm | Withdrawn |
| 0204-0020 | Length 80 mm | Withdrawn |
| 0217-4016 | Length 16 mm | Withdrawn |
| 0212-0016 | Length 32 mm | Withdrawn |
| 0204-0018 | Length 72 mm | Withdrawn |
| 0205-0019 | Length 95 mm | Withdrawn |
| 0214-0017 | Length 68 mm | Withdrawn |
| 0217-4512 | Length 12 mm | Withdrawn |
| 0204-0017 | Length 68 mm | Withdrawn |
| 0207-4018 | Length 18 mm | Withdrawn |
| 0204-0015 | Length 60 mm | Withdrawn |
| 0205-0020 | Length 100 mm | Withdrawn |
| 0203-0016 | Length 48 mm | Withdrawn |
| 0214-0014 | Length 56 mm | Withdrawn |
| 0213-0018 | Length 54 mm | Withdrawn |
| 0202-0014 | Length 28 mm | Withdrawn |
| 0212-0014 | Length 28 mm | Withdrawn |
| 0205-0014 | Length 70 mm | Withdrawn |
| 0204-0022 | Length 88 mm | Withdrawn |
| 0207-4512 | Length 12 mm | Withdrawn |
| 0213-0020 | Length 60 mm | Withdrawn |
| 0204-0014 | Length 56 mm | Withdrawn |
| 0201-0018 | Length 18 mm | Withdrawn |
| 0207-4514 | Length 14 mm | Withdrawn |
| 0213-0015 | Length 45 mm | Withdrawn |
| 0201-0026 | Length 26 mm | Withdrawn |
| 0212-0015 | Length 30 mm | Withdrawn |
| 0202-0015 | Length 30 mm | Withdrawn |
| 0202-0020 | Length 40 mm | Withdrawn |
| 0215-0022 | Length 110 mm | Withdrawn |
| 0201-0020 | Length 20 mm | Withdrawn |
| 0260-0001 | Withdrawn | |
| 0205-0022 | Length 110 mm | Withdrawn |
| 0215-0017 | Length 85 mm | Withdrawn |
| 0214-0018 | Length 72 mm | Withdrawn |
| 0202-0021 | Length 42 mm | Withdrawn |
| 0211-0024 | Length 24 mm | Withdrawn |
| 0217-4014 | Length 14 mm | Withdrawn |
| 0203-0018 | Length 54 mm | Withdrawn |
| 0206-4018 | Length 18 mm | Withdrawn |
| 0214-0016 | Length 64 mm | Withdrawn |
| 0215-0015 | Length 75 mm | Withdrawn |
| 0213-0019 | Length 57 mm | Withdrawn |
| 0205-0016 | Length 80 mm | Withdrawn |
| 0202-0019 | Length 38 mm | Withdrawn |
| 0201-0014 | Length 14 mm | Withdrawn |
| 0215-0018 | Length 90 mm | Withdrawn |
| 0207-4016 | Length 16 mm | Withdrawn |
| 0214-0020 | Length 80 mm | Withdrawn |
| 0204-0016 | Length 64 mm | Withdrawn |
| 0205-0015 | Length 75 mm | Withdrawn |
| 0204-0019 | Length 76 mm | Withdrawn |
| 0212-0021 | Length 42 mm | Withdrawn |
| 0216-4012 | Length 12 mm | Withdrawn |
| 0216-4014 | Length 14 mm | Withdrawn |
| 0206-4012 | Length 12 mm | Withdrawn |
| 0212-0018 | Length 36 mm | Withdrawn |
| 0212-0020 | Length 40 mm | Withdrawn |
| 0216-4016 | Length 16 mm | Withdrawn |
| 0204-0021 | Length 84 mm | Withdrawn |
| 0213-0017 | Length 51 mm | Withdrawn |
| 0215-0019 | Length 95 mm | Withdrawn |
| 0217-4012 | Length 12 mm | Withdrawn |
| 0217-4018 | Length 18 mm | Withdrawn |
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 |
|---|---|
| K251436 | 2025-07-11 |
| K222493 | 2022-11-18 |
| K211408 | 2021-06-23 |
| K130427 | 2013-06-05 |
| K120724 | 2012-05-07 |
| K111528 | 2011-08-24 |
| K100708 | 2010-06-04 |
| K090222 | 2009-04-28 |
| K083663 | 2009-02-25 |
| K072703 | 2008-01-10 |
| K053053 | 2005-11-16 |
| K043066 | 2005-02-03 |
Recalls
40 of these are 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 |
|---|---|---|---|---|
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | 65 units |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | |
| 2021-01-15 | Class II | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision |
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.