4CIS Will Pedicle Screw System
The 4CIS WILL Pedicle Screw System is a minimally invasive spinal fixation device used to stabilize the thoracic and lumbar spine during fusion surgery. It consists of polyaxial, cannulated…
The 4CIS WILL Pedicle Screw System is a minimally invasive spinal fixation device used to stabilize the thoracic and lumbar spine during fusion surgery. It consists of polyaxial, cannulated pedicle screws, rods, and set screws, allowing percutaneous insertion with minimal tissue damage.
15manufacturers in China registered for this device type
480catalogue numbers in this listing
1510(k) clearance
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 | Solco Biomedical Company India Private Limited, India |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K232607 |
| Record published | 2026-04-27 |
| Record revised | 2026-05-20 (version 2) |
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, serial number |
| Sizes | Length 25 to 480 mm |
| Distribution end date | 2026-05-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AISP-2801-5030 | Screw Diameter- 5.0 | In distribution |
| AISP-2801-5025 | Screw Diameter- 5.0 | In distribution |
| AISP-2801-5050 | Screw Diameter- 5.0 | In distribution |
| AISP-1058-6530 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1056-7065 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1527-5523 | Length 480 mm | Withdrawn |
| AISP-1058-6560 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1056-6570 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-2801-7050 | Screw Diameter- 7.0 | Withdrawn |
| AISP-1527-5518 | Length 180 mm | Withdrawn |
| AISP-1059-5550 | Screw Diameter- 5.5mm | Withdrawn |
| AIIN-0114-0030 | Withdrawn | |
| AISP-1058-7060 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1056-7075 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1056-6550 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1057-5035 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1056-6545 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1058-6040 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1058-5550 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1059-7060 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-7025 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1059-8030 | Screw Diameter-8.0mm | Withdrawn |
| AISP-2801-6060 | Screw Diameter- 6.0 | Withdrawn |
| AISP-1058-7035 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1058-6035 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1056-5050 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1057-6070 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-2801-6080 | Screw Diameter- 6.0 | Withdrawn |
| AISP-1056-6580 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1059-8575 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-1056-5550 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1526-5560 | Length 60 mm | Withdrawn |
| AISP-1056-7030 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1058-8060 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1526-5515 | Length 150 mm | Withdrawn |
| AISP-2801-7530 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1056-8050 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1527-5516 | Length 160 mm | Withdrawn |
| AIIN-0114-0003 | Withdrawn | |
| AISP-2801-7535 | Screw Diameter- 7.5mm | Withdrawn |
| AIIN-0114-0021 | Withdrawn | |
| AISP-1056-7565 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1058-8025 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1056-7560 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1057-8065 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1526-5517 | Length 170 mm | Withdrawn |
| AIIN-0105-0010 | Withdrawn | |
| AISP-1059-5050 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1058-7580 | Screw Diameter- 7.5mm | Withdrawn |
| AIIN-0114-0115 | Withdrawn | |
| AICN-1003-0001 | Withdrawn | |
| AISP-2801-8030 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1526-5512 | Length 120 mm | Withdrawn |
| AISP-1059-6075 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1526-5519 | Length 190 mm | Withdrawn |
| AISP-1059-5040 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-2801-8070 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1059-8530 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-1057-8030 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1057-6530 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1059-5030 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1058-6055 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1057-7030 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1056-5040 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1059-6025 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-2801-8060 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1057-5525 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1056-6565 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1057-7070 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1058-7550 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1059-8055 | Screw Diameter-8.0mm | Withdrawn |
| AISP-1527-5560 | Length 60 mm | Withdrawn |
| AISP-1059-6575 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-2801-7030 | Screw Diameter- 7.0 | Withdrawn |
| AISP-1056-7535 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1056-5055 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-2801-7560 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1056-5545 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1058-7080 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1059-8025 | Screw Diameter-8.0mm | Withdrawn |
| AISP-1058-8045 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1057-6075 | Screw Diameter- 6.0mm | Withdrawn |
| AIIN-0114-0044 | Dia 7.2mm | Withdrawn |
| AISP-1057-8070 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1526-5516 | Length 160 mm | Withdrawn |
| AISP-1056-7545 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1057-7565 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-2801-8075 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1057-5540 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1059-8560 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-1059-6555 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1526-5585 | DIAMETER 5.5MM | Withdrawn |
| AISP-1059-5525 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1059-5555 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1059-6525 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1059-7065 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-5050 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1056-5045 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1056-6050 | Screw Diameter- 6.0mm | Withdrawn |
| AIIN-0105-0033 | Withdrawn | |
| AISP-1526-5510 | Length 100 mm | Withdrawn |
| AISP-1058-7050 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-2801-7575 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1059-8510 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-1057-8045 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1058-8055 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1059-8535 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-1059-7030 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-7060 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-7580 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-2801-5530 | Screw Diameter- 5.5 | Withdrawn |
| AISP-2801-6045 | Screw Diameter- 6.0 | Withdrawn |
| AIIN-0114-0013 | Withdrawn | |
| AISP-1526-5514 | Length 140 mm | Withdrawn |
| AISP-1056-5535 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1058-8050 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-2801-7070 | Screw Diameter- 7.0 | Withdrawn |
| AISP-1057-5560 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1057-6050 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-2801-5045 | Screw Diameter- 5.0 | Withdrawn |
| AISP-1056-7050 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1059-7530 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1056-8045 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1520-0001 | Withdrawn | |
| AISP-2801-5035 | Screw Diameter- 5.0 | Withdrawn |
| AISP-1527-5550 | Length 50 mm | Withdrawn |
| AISP-1056-6065 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1056-7045 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-5045 | Screw Diameter- 5.0mm | Withdrawn |
| AIIN-0114-0006 | Withdrawn | |
| AISP-1057-8075 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1527-5540 | Length 40 mm | Withdrawn |
| AISP-1526-5513 | Length 130 mm | Withdrawn |
| AIIN-0114-0008 | Withdrawn | |
| AISP-2801-7540 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1059-5535 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1057-6025 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1058-5035 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1059-7525 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1058-6030 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1059-7035 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1058-7560 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1059-5035 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1059-8565 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-1056-8060 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1057-6555 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1058-7555 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1058-7070 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1056-6555 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1056-6040 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-2801-7080 | Screw Diameter- 7.0 | Withdrawn |
| AISP-1056-7035 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-7570 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-2801-5560 | Screw Diameter- 5.5 | Withdrawn |
| AISP-1057-6565 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1059-7070 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1059-8080 | Screw Diameter-8.0mm | Withdrawn |
| AISP-1526-5590 | DIAMETER 5.5MM | Withdrawn |
| AISP-1056-8075 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1057-6045 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1058-6550 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1059-7545 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1059-7040 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1527-5517 | Diameter 5.5 | Withdrawn |
| AISP-2801-7525 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1057-7560 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1057-6560 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1057-7545 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-2801-6580 | Screw Diameter- 6.5 | Withdrawn |
| AISP-2801-8050 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1059-7555 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1526-5580 | DIAMETER 5.5MM | Withdrawn |
| AISP-1057-7065 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-2801-5540 | Screw Diameter- 5.5 | Withdrawn |
| AISP-1527-5515 | Diameter 5.5 | Withdrawn |
| AISP-1057-7530 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-2801-8040 | Screw Diameter- 8.0mm | Withdrawn |
| AIIN-0114-0009 | Withdrawn | |
| AISP-1057-7525 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1058-5055 | Screw Diameter- 5.0mm | Withdrawn |
| AIIN-0114-0043 | Dia 6.2mm | Withdrawn |
| AISP-1057-5550 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-2801-6555 | Screw Diameter- 6.5 | Withdrawn |
| AISP-1058-5060 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1526-5511 | Length 110 mm | Withdrawn |
| AISP-2801-6535 | Screw Diameter- 6.5 | Withdrawn |
| AISP-1056-7040 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-6540 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1059-7550 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1056-5060 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1056-5035 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1059-7560 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1058-5535 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1057-6055 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1526-5545 | Length 45 mm | Withdrawn |
| AIIN-0114-0001 | Withdrawn | |
| AISP-2801-7075 | Screw Diameter- 7.0 | Withdrawn |
| AISP-2801-5055 | Screw Diameter- 5.0 | Withdrawn |
| AISP-1057-5535 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1057-8040 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-2801-6030 | Screw Diameter- 6.0 | Withdrawn |
| AISP-1057-7040 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1059-7050 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-6035 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1058-6540 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1057-5055 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-1056-6075 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1059-8580 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-1057-6525 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1058-7030 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1058-7040 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1058-7530 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1056-7025 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1056-6530 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1057-7035 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1056-7080 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1059-6050 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-2801-8055 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1057-8060 | Screw Diameter- 8.0mm | Withdrawn |
| AIIN-0114-0022 | Withdrawn | |
| AISP-2801-7055 | Screw Diameter- 7.0 | Withdrawn |
| AIIN-0114-0041 | Dia 4.2mm | Withdrawn |
| AISP-1526-5560 | Length 60 mm | Withdrawn |
| AISP-2801-7555 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1056-6070 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1058-6565 | Screw Diameter- 6.5mm | Withdrawn |
| AIIN-0114-0017 | Withdrawn | |
| AISP-1056-6540 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1057-7045 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-7555 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1057-5545 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1059-8590 | Screw Diameter- 8.5mm | Withdrawn |
| AISP-2801-5040 | Screw Diameter- 5.0 | Withdrawn |
| AISP-1057-6080 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1057-7080 | Screw Diameter- 7.0mm | Withdrawn |
| AIIN-0105-0014 | Withdrawn | |
| AISP-1059-7535 | Screw Diameter- 7.5mm | Withdrawn |
| AIIN-0105-0021 | Withdrawn | |
| AISP-1059-5545 | Screw Diameter- 5.5mm | Withdrawn |
| AISP-1526-5520 | Length 200 mm | Withdrawn |
| AISP-1058-8030 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1056-7055 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1057-5040 | Screw Diameter- 5.0mm | Withdrawn |
| AISP-2801-8025 | Screw Diameter- 8.0mm | Withdrawn |
| AISP-1059-7565 | Screw Diameter- 7.5mm | Withdrawn |
| AISP-1057-6550 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1058-7055 | Screw Diameter- 7.0mm | Withdrawn |
| AISP-1058-6025 | Screw Diameter- 6.0mm | Withdrawn |
| AISP-1059-6530 | Screw Diameter- 6.5mm | Withdrawn |
| AISP-1056-6035 | Screw Diameter- 6.0mm | Withdrawn |
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 |
|---|---|
| K202498 | 2021-02-18 |
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.