Valencia Pedicle Screw System
6.5mm x 55mm Multiaxial Self Tapping Pedicle Screw
11manufacturers in China registered for this device type
163catalogue 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 | Altus Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K033352 |
| Record published | 2016-10-28 |
| Record revised | 2024-09-11 (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, manufacturing date |
| Sizes | Length 25 to 400 mm; outer diameter 4.5 to 8.5 mm; height 7 to 10 mm; needle gauge 8 G |
| Distribution end date | 2023-12-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 990-7525 | Length 25 mm | In distribution |
| 913-5125 | Length 125 mm | In distribution |
| 940-7535 | Length 35 mm | In distribution |
| 983-7555 | Length 55 mm | In distribution |
| 970-5535 | Outer Diameter 5.5 mm | In distribution |
| 923-5060 | Outer Diameter 5.5 mm | In distribution |
| 990-5530 | Outer Diameter 5.5 mm | In distribution |
| 970-7565 | Outer Diameter 7.5 mm | In distribution |
| 913- 5150M | Outer Diameter 5.5 mm | In distribution |
| 913-5065 | Length 65 mm | In distribution |
| 940-5545 | Length 45 mm | In distribution |
| 916-0099 | In distribution | |
| 913-5130 | Length 130 mm | In distribution |
| 973-5565 | Length 65 mm | In distribution |
| 970-8600 | Outer Diameter 8.5 mm | In distribution |
| 983-6525 | Length 25 mm | In distribution |
| 993-7575 | Length 75 mm | In distribution |
| 940-6555 | Length 55 mm | In distribution |
| 940-8550 | Outer Diameter 8.5 mm | In distribution |
| 908-1203 | In distribution | |
| 930-8525 | Length 25 mm | In distribution |
| 908-0013 | In distribution | |
| 943-8530 | Length 30 mm | In distribution |
| 970-6530 | Length 30 mm | In distribution |
| 973-5555 | Outer Diameter 5.5 mm | In distribution |
| 943-8575 | Length 75 mm | In distribution |
| 975-8555 | Outer Diameter 8.5 mm | In distribution |
| 913-5055 | Outer Diameter 5.5 mm | In distribution |
| 993-7585 | Length 85 mm | In distribution |
| 993-8540 | Length 40 mm | In distribution |
| 923-5160 | Length 160 mm | In distribution |
| 940-5535 | Outer Diameter 5.5 mm | In distribution |
| 993-7565 | Outer Diameter 7.5 mm | In distribution |
| 973-8580 | Length 80 mm | In distribution |
| 943-7595 | Outer Diameter 7.5 mm | In distribution |
| 973-5540 | Outer Diameter 5.5 mm | In distribution |
| 913- 5200M | Outer Diameter 5.5 mm | In distribution |
| 940-8555 | Length 55 mm | In distribution |
| 970-7540 | Length 40 mm | In distribution |
| 975-5545 | Outer Diameter 5.5 mm | In distribution |
| 913-5175 | Outer Diameter 5.5 mm | In distribution |
| 943-5535 | Outer Diameter 5.5 mm | In distribution |
| 940-5530 | Length 30 mm | In distribution |
| 980-5535 | Outer Diameter 5.5 mm | In distribution |
| 923-5140 | Length 140 mm | In distribution |
| 975-8585 | Length 85 mm | In distribution |
| 930-8530 | Outer Diameter 8.5 mm | In distribution |
| 924-5620 | Outer Diameter 5.5 mm | In distribution |
| 993-4560 | Length 60 mm | In distribution |
| 993-5550 | Outer Diameter 5.5 mm | In distribution |
| 943-7590 | Length 90 mm | In distribution |
| 993-8575 | Outer Diameter 8.5 mm | In distribution |
| 975-8540 | Outer Diameter 8.5 mm | In distribution |
| 923-5055 | Length 55 mm | In distribution |
| 913-5135 | Outer Diameter 5.5 mm | In distribution |
| 990-7550 | Outer Diameter 7.5 mm | In distribution |
| 909-8150 | Needle Gauge 8 G | In distribution |
| 908-0045 | In distribution | |
| 943-7550 | Length 50 mm | In distribution |
| 975-4530 | Outer Diameter 4.5 mm | In distribution |
| 983-5530 | Length 30 mm | In distribution |
| 905-0032 | In distribution | |
| 940-7555 | Outer Diameter 7.5 mm | In distribution |
| 940-6550 | Outer Diameter 6.5 mm | In distribution |
| 900-1021 | In distribution | |
| 950-6530 | Outer Diameter 6.5 mm | In distribution |
| 990-8560 | Length 60 mm | In distribution |
| 913-5070 | Outer Diameter 5.5 mm | In distribution |
| 993-6530 | Outer Diameter 6.5 mm | In distribution |
| 973-5525 | Outer Diameter 5.5 mm | In distribution |
| 990-7555 | Outer Diameter 7.5 mm | In distribution |
| 943-7525 | Outer Diameter 7.5 mm | In distribution |
| 990-4525 | Outer Diameter 4.5 mm | In distribution |
| 940-7550 | Outer Diameter 7.5 mm | In distribution |
| 993-4550 | Length 50 mm | In distribution |
| 975-7525 | Length 25 mm | In distribution |
| 930-7550 | Length 50 mm | In distribution |
| 923-5080 | Outer Diameter 5.5 mm | In distribution |
| 913-5100 | Length 100 mm | In distribution |
| 990-4560 | Outer Diameter 4.5 mm | In distribution |
| 900-1000 | In distribution | |
| 973-7595 | Length 95 mm | In distribution |
| 975-8595 | Length 95 mm | In distribution |
| 973-4560 | Outer Diameter 4.5 mm | In distribution |
| 930-6555 | Length 55 mm | In distribution |
| 983-6555 | Outer Diameter 6.5 mm | In distribution |
| 973-7525 | Length 25 mm | In distribution |
| 975-6545 | Length 45 mm | In distribution |
| 983-8555 | Outer Diameter 8.5 mm | In distribution |
| 990-7575 | Outer Diameter 7.5 mm | In distribution |
| 983-5535 | Outer Diameter 5.5 mm | In distribution |
| 993-5535 | Outer Diameter 5.5 mm | In distribution |
| 993-4525 | Length 25 mm | In distribution |
| 950-8560 | Length 60 mm | In distribution |
| 943-7540 | Length 40 mm | In distribution |
| 980-8545 | Outer Diameter 8.5 mm | In distribution |
| 913-5105 | Length 105 mm | In distribution |
| 993-8560 | Length 60 mm | In distribution |
| 943-8550 | Outer Diameter 8.5 mm | In distribution |
| 913-5400 | Length 400 mm | In distribution |
| 943-5555 | Length 55 mm | In distribution |
| 970-7575 | Length 75 mm | In distribution |
| 993-7545 | Outer Diameter 7.5 mm | In distribution |
| 923-5065 | Length 65 mm | In distribution |
| 905-0020 | In distribution | |
| 913-5145 | Outer Diameter 5.5 mm | In distribution |
| 970-8575 | Length 75 mm | In distribution |
| 909-1055 | In distribution | |
| 900-1007 | In distribution | |
| 950-7550 | Length 50 mm | In distribution |
| 973-8595 | Length 95 mm | In distribution |
| 923-5125 | Outer Diameter 5.5 mm | In distribution |
| 983-7540 | Outer Diameter 7.5 mm | In distribution |
| 980-6550 | Length 50 mm | In distribution |
| 905-0008 | In distribution | |
| 913- 5110M | Length 110 mm | In distribution |
| 916-3544 | 35-44mm | In distribution |
| 990-4555 | Length 55 mm | In distribution |
| 970-8560 | Outer Diameter 8.5 mm | In distribution |
| 924-5635 | Length 135 mm | In distribution |
| 973-7570 | Outer Diameter 7.5 mm | In distribution |
| 983-5550 | Outer Diameter 5.5 mm | In distribution |
| 940-8530 | Length 30 mm | In distribution |
| 923-5130 | Length 130 mm | In distribution |
| 924-5605 | Outer Diameter 5.5 mm | In distribution |
| 980-6560 | Outer Diameter 6.5 mm | In distribution |
| 930-5530 | Outer Diameter 5.5 mm | In distribution |
| 940-5560 | Outer Diameter 5.5 mm | In distribution |
| 940-8560 | Length 60 mm | In distribution |
| 923-5050 | Length 50 mm | In distribution |
| 990-5555 | Outer Diameter 5.5 mm | In distribution |
| 905-1011 | In distribution | |
| 973-8600 | Outer Diameter 8.5 mm | In distribution |
| 993-8530 | Length 30 mm | In distribution |
| 980-7540 | Length 40 mm | In distribution |
| 975-8580 | Length 80 mm | In distribution |
| 960-4560 | Outer Diameter 4.5 mm | Withdrawn |
| 960-4550 | Length 50 mm | Withdrawn |
| 925-5535 | Length 35 mm | Withdrawn |
| 925-7555 | Outer Diameter 7.5 mm | Withdrawn |
| 925-5545 | Length 45 mm | Withdrawn |
| 925-4530 | Outer Diameter 4.5 mm | Withdrawn |
| 922-6555 | Outer Diameter 6.5 mm | Withdrawn |
| 960-6535 | Outer Diameter 6.5 mm | Withdrawn |
| 960-8530 | Outer Diameter 8.5 mm | Withdrawn |
| 922-5540 | Length 40 mm | Withdrawn |
| 960-7560 | Length 60 mm | Withdrawn |
| 960-4525 | Length 25 mm | Withdrawn |
| 925-6540 | Length 40 mm | Withdrawn |
| 925-4555 | Length 55 mm | Withdrawn |
| 944-0100 | Height 10 mm | Withdrawn |
| 925-8545 | Length 45 mm | Withdrawn |
| 925-4525 | Length 25 mm | Withdrawn |
| 960-4530 | Outer Diameter 4.5 mm | Withdrawn |
| 960-5555 | Length 55 mm | Withdrawn |
| 944-0070 | Height 7 mm | Withdrawn |
| 925-4540 | Outer Diameter 4.5 mm | Withdrawn |
| 925-8535 | Length 35 mm | Withdrawn |
| 925-6545 | Length 45 mm | Withdrawn |
| 922-7555 | Length 55 mm | Withdrawn |
| 960-6530 | Outer Diameter 6.5 mm | Withdrawn |
| 925-6540 | Length 40 mm | Withdrawn |
| 922-8545 | Length 45 mm | Withdrawn |
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.