Salvo® Spine System
Salvo Spine System is a posterior pedicle screw system that stabilizes the thoracic, lumbar and sacral spine as an adjunct to fusion. Screws, rods and cross-connectors join to form a rigid…
Salvo Spine System is a posterior pedicle screw system that stabilizes the thoracic, lumbar and sacral spine as an adjunct to fusion. Screws, rods and cross-connectors join to form a rigid internal fixation construct.
The family includes components made from titanium alloy, commercially pure titanium and cobalt-chromium alloy. These are material options across the implant range; a particular screw, rod or connector represents one part of the assembled system.
Listed Item
Connector, Lateral Offset, 4.75/6.35 (O), 5.5 mm x 40 mm
Construct Components
Screws anchor fixation points in vertebral bone, rods connect those points, and connectors link parts of the construct. The range is intended for skeletally mature patients, with component selection and assembly defined by the spinal fixation configuration.
15manufacturers in China registered for this device type
394catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Spine Wave, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K182954 |
| Record published | 2026-01-09 |
| Record revised | 2025-07-14 (version 4) |
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 | Outer diameter 4.5 to 10.5 mm; length 25 to 300 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-6735 | Outer Diameter 9.5 mm | In distribution |
| 11-6666 | Outer Diameter 4.5 mm | In distribution |
| 11-7603 | In distribution | |
| 11-6402 | In distribution | |
| 11-7016 | In distribution | |
| 11-6613 | Outer Diameter 9.5 mm | In distribution |
| 11-6564 | Outer Diameter 7.5 mm | In distribution |
| 11-6404 | In distribution | |
| 11-6804 | Outer Diameter 6.5 mm | In distribution |
| 21-0034 | Outer Diameter 8.5 mm | In distribution |
| 11-6714 | Outer Diameter 8.5 mm | In distribution |
| 11-6558 | Length 50 mm | In distribution |
| 11-7601 | In distribution | |
| 11-6860 | Outer Diameter 9.5 mm | In distribution |
| 21-0062 | Outer Diameter 9.5 mm | In distribution |
| 11-7610 | In distribution | |
| 11-7410 | In distribution | |
| 11-7451 | Outer Diameter 4.75 mm | In distribution |
| 11-6662 | Length 40 mm | In distribution |
| 11-7279 | Outer Diameter 4.75 mm | In distribution |
| 11-7949 | In distribution | |
| 21-0085 | Outer Diameter 10.5 mm | In distribution |
| 11-7280 | Length 70 mm | In distribution |
| 21-0032 | Outer Diameter 8.5 mm | In distribution |
| 11-6988 | Outer Diameter 9.5 mm | In distribution |
| 11-6545 | Length 30 mm | In distribution |
| 21-0061 | Outer Diameter 9.5 mm | In distribution |
| 11-7385 | In distribution | |
| 11-7553 | In distribution | |
| 11-7401 | In distribution | |
| 11-6669 | Length 35 mm | In distribution |
| 11-6546 | Outer Diameter 5.5 mm | In distribution |
| 11-7457 | Outer Diameter 4.75 mm | In distribution |
| 11-6664 | Outer Diameter 4.5 mm | In distribution |
| 11-7495 | In distribution | |
| 11-6841 | Outer Diameter 8.5 mm | In distribution |
| 11-6814 | Outer Diameter 7.5 mm | In distribution |
| 11-6532 | In distribution | |
| 10-8480 | In distribution | |
| 11-6961 | Outer Diameter 8.5 mm | In distribution |
| 11-6919 | Outer Diameter 5.5 mm | In distribution |
| 11-6792 | Outer Diameter 5.5 mm | In distribution |
| 11-6736 | Outer Diameter 9.5 mm | In distribution |
| 11-6905 | Outer Diameter 4.5 mm | In distribution |
| 11-6914 | Outer Diameter 5.5 mm | In distribution |
| 11-6948 | Outer Diameter 7.5 mm | In distribution |
| 11-6679 | Outer Diameter 6.5 mm | In distribution |
| 11-6946 | Outer Diameter 7.5 mm | In distribution |
| 11-7376 | In distribution | |
| 11-7398 | In distribution | |
| 11-7609 | In distribution | |
| 11-6536 | Length 25 mm | In distribution |
| 11-6555 | Outer Diameter 6.5 mm | In distribution |
| 11-7389 | In distribution | |
| 11-7384 | In distribution | |
| 11-7063 | Length 55 mm | In distribution |
| 11-6685 | Length 25 mm | In distribution |
| 11-6786 | Outer Diameter 4.5 mm | In distribution |
| 11-7284 | Outer Diameter 4.75 mm | In distribution |
| 11-7541 | In distribution | |
| 11-6401 | In distribution | |
| 11-6957 | Outer Diameter 8.5 mm | In distribution |
| 11-6667 | Length 25 mm | In distribution |
| 11-6918 | Outer Diameter 5.5 mm | In distribution |
| 21-0063 | Outer Diameter 9.5 mm | In distribution |
| 11-6924 | Outer Diameter 6.5 mm | In distribution |
| 11-7602 | In distribution | |
| 11-6871 | Outer Diameter 9.5 mm | In distribution |
| 11-7388 | In distribution | |
| 11-6553 | Outer Diameter 6.5 mm | In distribution |
| 11-7461 | Outer Diameter 4.75 mm | In distribution |
| 11-9586 | In distribution | |
| 11-6615 | Outer Diameter 9.5 mm | In distribution |
| 11-9578 | In distribution | |
| 11-6683 | Outer Diameter 6.5 mm | In distribution |
| 11-6998 | Outer Diameter 9.5 mm | In distribution |
| 11-6678 | Length 35 mm | In distribution |
| 11-6616 | Outer Diameter 9.5 mm | In distribution |
| 11-7455 | Outer Diameter 4.75 mm | In distribution |
| 11-6922 | Outer Diameter 6.5 mm | In distribution |
| 11-6692 | Outer Diameter 7.5 mm | In distribution |
| 11-6690 | Outer Diameter 7.5 mm | In distribution |
| 11-7392 | In distribution | |
| 11-7277 | Outer Diameter 4.75 mm | In distribution |
| 11-7467 | Outer Diameter 4.75 mm | In distribution |
| 21-0041 | Outer Diameter 8.5 mm | In distribution |
| 11-6563 | Length 30 mm | In distribution |
| 11-6672 | Outer Diameter 5.5 mm | In distribution |
| 11-6891 | Outer Diameter 10.5 mm | In distribution |
| 11-6839 | Outer Diameter 8.5 mm | In distribution |
| 11-6958 | Outer Diameter 8.5 mm | In distribution |
| 11-6990 | Outer Diameter 9.5 mm | In distribution |
| 11-8649 | Outer Diameter 5.5 mm | In distribution |
| 11-6867 | Outer Diameter 9.5 mm | In distribution |
| 11-7390 | In distribution | |
| 11-6944 | Outer Diameter 7.5 mm | In distribution |
| 11-6403 | In distribution | |
| 21-0067 | Outer Diameter 9.5 mm | In distribution |
| 11-7062 | Outer Diameter 4.75 mm | In distribution |
| 11-7288 | Outer Diameter 4.75 mm | In distribution |
| 11-7405 | In distribution | |
| 11-9583 | In distribution | |
| 11-7543 | In distribution | |
| 11-6790 | Outer Diameter 5.5 mm | In distribution |
| 11-9638 | In distribution | |
| 11-7408 | In distribution | |
| 11-7278 | Length 60 mm | In distribution |
| 11-7393 | In distribution | |
| 11-6787 | Outer Diameter 4.5 mm | In distribution |
| 11-6684 | Outer Diameter 6.5 mm | In distribution |
| 11-6862 | Outer Diameter 9.5 mm | In distribution |
| 11-6659 | Outer Diameter 4.5 mm | In distribution |
| 11-7454 | Outer Diameter 4.75 mm | In distribution |
| 11-6549 | Length 50 mm | In distribution |
| 11-6960 | Outer Diameter 8.5 mm | In distribution |
| 11-9577 | In distribution | |
| 11-6913 | Outer Diameter 5.5 mm | In distribution |
| 11-6712 | Outer Diameter 8.5 mm | In distribution |
| 11-6713 | Outer Diameter 8.5 mm | In distribution |
| 11-7496 | In distribution | |
| 11-6806 | Outer Diameter 6.5 mm | In distribution |
| 11-6673 | Outer Diameter 5.5 mm | In distribution |
| 11-6677 | Outer Diameter 6.5 mm | In distribution |
| 11-6534 | In distribution | |
| 11-6835 | Outer Diameter 8.5 mm | In distribution |
| 11-7465 | Outer Diameter 4.75 mm | In distribution |
| 11-8647 | Outer Diameter 5.5 mm | In distribution |
| 11-7608 | In distribution | |
| 11-6964 | Outer Diameter 8.5 mm | In distribution |
| 11-7561 | Outer Diameter 6.0 mm | In distribution |
| 11-6915 | Outer Diameter 5.5 mm | In distribution |
| 11-6935 | Outer Diameter 7.5 mm | In distribution |
| 11-9590 | In distribution | |
| 11-6884 | Outer Diameter 10.5 mm | In distribution |
| 21-0065 | Outer Diameter 9.5 mm | In distribution |
| 11-6809 | Outer Diameter 7.5 mm | In distribution |
| 11-7391 | In distribution | |
| 10-6133 | In distribution | |
| 11-6933 | Outer Diameter 7.5 mm | In distribution |
| 11-6810 | Outer Diameter 7.5 mm | In distribution |
| 11-6885 | Outer Diameter 10.5 mm | In distribution |
| 11-7059 | Length 35 mm | In distribution |
| 11-6680 | Length 45 mm | In distribution |
| 11-7494 | In distribution | |
| 11-7412 | In distribution | |
| 11-6883 | Outer Diameter 10.5 mm | In distribution |
| 11-9680 | In distribution | |
| 11-6959 | Outer Diameter 8.5 mm | In distribution |
| 11-7400 | In distribution | |
| 11-7060 | Outer Diameter 4.75 mm | In distribution |
| 11-7453 | Outer Diameter 4.75 mm | In distribution |
| 11-7070 | Length 90 mm | In distribution |
| 11-7544 | In distribution | |
| 11-6682 | Outer Diameter 6.5 mm | In distribution |
| 11-6968 | Outer Diameter 8.5 mm | In distribution |
| 11-7076 | Outer Diameter 4.75 mm | In distribution |
| 11-6782 | Outer Diameter 4.5 mm | In distribution |
| 21-0033 | Outer Diameter 8.5 mm | In distribution |
| 11-7509 | In distribution | |
| 11-6869 | Outer Diameter 9.5 mm | In distribution |
| 11-6612 | Outer Diameter 9.5 mm | In distribution |
| 11-6834 | Outer Diameter 8.5 mm | In distribution |
| 11-7068 | Outer Diameter 4.75 mm | In distribution |
| 11-7542 | In distribution | |
| 11-6527 | In distribution | |
| 11-6916 | Outer Diameter 5.5 mm | In distribution |
| 11-6801 | Outer Diameter 6.5 mm | In distribution |
| 11-6665 | Outer Diameter 4.5 mm | In distribution |
| 11-7414 | In distribution | |
| 11-6799 | Outer Diameter 6.5 mm | In distribution |
| 11-7613 | In distribution | |
| 11-7402 | In distribution | |
| 11-7413 | In distribution | |
| 11-7938 | In distribution | |
| 11-6675 | Outer Diameter 5.5 mm | In distribution |
| 11-6994 | Outer Diameter 9.5 mm | In distribution |
| 11-9576 | In distribution | |
| 21-0035 | Outer Diameter 8.5 mm | In distribution |
| 11-6556 | Length 40 mm | In distribution |
| 11-6687 | Length 35 mm | In distribution |
| 11-6688 | Outer Diameter 7.5 mm | In distribution |
| 11-6793 | Outer Diameter 5.5 mm | In distribution |
| 11-7386 | In distribution | |
| 11-9659 | In distribution | |
| 11-7275 | Outer Diameter 4.75 mm | In distribution |
| 11-6540 | Length 45 mm | In distribution |
| 11-6784 | Outer Diameter 4.5 mm | In distribution |
| 11-7619 | In distribution | |
| 11-9580 | In distribution | |
| 11-7549 | In distribution | |
| 11-6559 | Outer Diameter 6.5 mm | In distribution |
| 11-6974 | Outer Diameter 8.5 mm | In distribution |
| 11-7416 | In distribution | |
| 10-8427 | In distribution | |
| 11-6962 | Outer Diameter 8.5 mm | In distribution |
| 11-7555 | In distribution | |
| 11-6920 | Outer Diameter 5.5 mm | In distribution |
| 11-6992 | Outer Diameter 9.5 mm | In distribution |
| 11-6668 | Outer Diameter 5.5 mm | In distribution |
| 11-6711 | Outer Diameter 8.5 mm | In distribution |
| 11-6791 | Outer Diameter 5.5 mm | In distribution |
| 11-7100 | In distribution | |
| 11-6934 | Outer Diameter 7.5 mm | In distribution |
| 11-7604 | In distribution | |
| 11-9574 | In distribution | |
| 11-7381 | In distribution | |
| 11-6550 | Outer Diameter 5.5 mm | In distribution |
| 11-7503 | In distribution | |
| 11-7460 | Outer Diameter 4.75 mm | In distribution |
| 11-7282 | Length 80 mm | In distribution |
| 11-7563 | Outer Diameter 6.0 mm | In distribution |
| 21-0008 | In distribution | |
| 11-7947 | In distribution | |
| 11-9581 | In distribution | |
| 11-6539 | Outer Diameter 4.5 mm | In distribution |
| 11-7615 | In distribution | |
| 11-7383 | In distribution | |
| 11-6794 | Outer Diameter 5.5 mm | In distribution |
| 11-6972 | Outer Diameter 8.5 mm | In distribution |
| 11-6906 | Outer Diameter 4.5 mm | In distribution |
| 11-7548 | In distribution | |
| 10-8282 | Length 30 mm | In distribution |
| 11-6940 | Outer Diameter 7.5 mm | In distribution |
| 11-9588 | In distribution | |
| 11-7452 | Outer Diameter 4.75 mm | In distribution |
| 11-6893 | Outer Diameter 10.5 mm | In distribution |
| 11-7547 | In distribution | |
| 11-6836 | Outer Diameter 8.5 mm | In distribution |
| 10-8359 | In distribution | |
| 11-7937 | In distribution | |
| 11-6927 | Outer Diameter 6.5 mm | In distribution |
| 11-7274 | Length 40 mm | In distribution |
| 11-6908 | Outer Diameter 4.5 mm | In distribution |
| 11-9582 | In distribution | |
| 11-6815 | Outer Diameter 7.5 mm | In distribution |
| 11-7546 | In distribution | |
| 11-6882 | Outer Diameter 10.5 mm | In distribution |
| 11-6910 | Outer Diameter 4.5 mm | In distribution |
| 11-6802 | Outer Diameter 6.5 mm | In distribution |
| 11-6932 | Outer Diameter 7.5 mm | In distribution |
| 11-6691 | Outer Diameter 7.5 mm | In distribution |
| 11-7407 | In distribution | |
| 11-7271 | Outer Diameter 4.75 mm | In distribution |
| 11-6617 | Outer Diameter 9.5 mm | In distribution |
| 11-6925 | Outer Diameter 6.5 mm | In distribution |
| 11-6970 | Outer Diameter 8.5 mm | In distribution |
| 11-6812 | Outer Diameter 7.5 mm | In distribution |
| 11-7397 | In distribution | |
| 11-7394 | In distribution | |
| 11-6530 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251131 | 2025-06-06 |
| K240685 | 2024-05-06 |
| K222362 | 2022-08-29 |
| K202476 | 2020-11-05 |
| K191045 | 2019-07-10 |
| K182954 | 2018-12-12 |
| K172175 | 2017-08-16 |
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.