Whistler Modular Pedicle Screw System
Whistler Modular Pedicle Screw System is a posterior spinal fixation family built from screws, rods and locking components. Rods link the bone-anchored screws into a construct that…
Whistler Modular Pedicle Screw System is a posterior spinal fixation family built from screws, rods and locking components. Rods link the bone-anchored screws into a construct that immobilizes spinal segments as an adjunct to fusion.
The titanium alloy implant range includes solid and cannulated screws and open, reduction or MIS screw-head configurations. Screw options are offered with or without hydroxyapatite coating.
Listed Item
Ti Open Straight Rod, 5.5 Dia x 300 mm
Rod and Supply Options
The system uses 5.5 or 6 mm diameter rods with different lengths and contours. Implants are available sterile or nonsterile and intended for single use, so an individual rod represents one connecting component within the modular construct.
15manufacturers in China registered for this device type
466catalogue 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 | Evolution Spine, LLC, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K182478 |
| Record published | 2021-05-17 |
| Record revised | 2025-07-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 4.75 to 10.5 mm; length 25 to 500 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WRS55300-TO | Outer Diameter 5.5 mm | In distribution |
| WRS5570-C | Length 70 mm | In distribution |
| WS8570-H | Outer Diameter 8.5 mm | In distribution |
| WS7580-H | Length 80 mm | In distribution |
| WRS6070-T | Length 70 mm | In distribution |
| WRC5540-T | Length 40 mm | In distribution |
| WRS6030-T | Length 30 mm | In distribution |
| WC7560-N | Length 60 mm | In distribution |
| WS5545-N | Length 45 mm | In distribution |
| WS6550-N | Length 50 mm | In distribution |
| WC6530-H | Length 30 mm | In distribution |
| WRC6050-C | Outer Diameter 6 mm | In distribution |
| WI-013-R-510S | In distribution | |
| WRS5575-C | Length 75 mm | In distribution |
| WS6535-H | Outer Diameter 6.5 mm | In distribution |
| WC6560-H | Outer Diameter 6.5 mm | In distribution |
| WC8555-H | Outer Diameter 8.5 mm | In distribution |
| WRC55500-C | Length 500 mm | In distribution |
| WRS55200-T | Outer Diameter 5.5 mm | In distribution |
| WRC60130-T | Length 130 mm | In distribution |
| WRC5575-C | Outer Diameter 5.5 mm | In distribution |
| WRC5560-TO | Outer Diameter 5.5 mm | In distribution |
| WRS60400-C | Outer Diameter 6 mm | In distribution |
| WRC55150-C | Outer Diameter 5.5 mm | In distribution |
| WS75100-H | Length 100 mm | In distribution |
| WRS6080-T | Length 80 mm | In distribution |
| WRC55300-T | Length 300 mm | In distribution |
| WS9575-H | Length 75 mm | In distribution |
| WRS60100-T | Outer Diameter 6 mm | In distribution |
| WS10535-H | Outer Diameter 10.5 mm | In distribution |
| WRC55150-T | Outer Diameter 5.5 mm | In distribution |
| WRS5565-T | Length 65 mm | In distribution |
| WRS60400-T | Length 400 mm | In distribution |
| WRS55110-C | Outer Diameter 5.5 mm | In distribution |
| WS7530-N | Length 30 mm | In distribution |
| WC6540-N | Outer Diameter 6.5 mm | In distribution |
| WRS5560-TO | Outer Diameter 5.5 mm | In distribution |
| WC8560-N | Length 60 mm | In distribution |
| WRS5590-C | Length 90 mm | In distribution |
| WRC6070-C | Length 70 mm | In distribution |
| WRS55200-C | Length 200 mm | In distribution |
| WRC60130-C | Outer Diameter 6 mm | In distribution |
| WC5540-N | Length 40 mm | In distribution |
| WS9570-N | Length 70 mm | In distribution |
| WRS6090-C | Outer Diameter 6 mm | In distribution |
| WRS6065-C | Outer Diameter 6 mm | In distribution |
| WS7540-H | Outer Diameter 7.5 mm | In distribution |
| WRC5580-T | Length 80 mm | In distribution |
| WS7555-N | Outer Diameter 7.5 mm | In distribution |
| WRS6075-C | Length 75 mm | In distribution |
| WS10575-N | Outer Diameter 10.5 mm | In distribution |
| WRC5535-TO | Length 35 mm | In distribution |
| WRS60200-C | Outer Diameter 6 mm | In distribution |
| WC5535-N | Length 35 mm | In distribution |
| WRC60150-C | Length 150 mm | In distribution |
| WRS60150-C | Outer Diameter 6 mm | In distribution |
| WRS60110-T | Outer Diameter 6 mm | In distribution |
| WS6530-N | Outer Diameter 6.5 mm | In distribution |
| WS9590-H | Outer Diameter 9.5 mm | In distribution |
| WRS60140-C | Outer Diameter 6 mm | In distribution |
| WS7570-N | Length 70 mm | In distribution |
| WS4725-H | Outer Diameter 4.75 mm | In distribution |
| WRS55150-T | Length 150 mm | In distribution |
| WRC5550-T | Outer Diameter 5.5 mm | In distribution |
| WRC60300-T | Length 300 mm | In distribution |
| WRC6055-C | Outer Diameter 6 mm | In distribution |
| WS8535-N | Length 35 mm | In distribution |
| WS105110-N | Outer Diameter 10.5 mm | In distribution |
| WRS6055-C | Length 55 mm | In distribution |
| WRC55200-TO | Outer Diameter 5.5 mm | In distribution |
| WS105120-N | Outer Diameter 10.5 mm | In distribution |
| WRC5560-C | Outer Diameter 5.5 mm | In distribution |
| WS9570-H | Length 70 mm | In distribution |
| WS6550-H | Outer Diameter 6.5 mm | In distribution |
| WRC5565-T | Outer Diameter 5.5 mm | In distribution |
| WC8540-H | Length 40 mm | In distribution |
| WS4730-N | Outer Diameter 4.75 mm | In distribution |
| WS95110-N | Length 110 mm | In distribution |
| WRS55120-T | Outer Diameter 5.5 mm | In distribution |
| WS6540-H | Length 40 mm | In distribution |
| WRC55200-C | Outer Diameter 5.5 mm | In distribution |
| WS10530-H | Outer Diameter 10.5 mm | In distribution |
| WRS5530-TO | Length 30 mm | In distribution |
| WC5545-N | Length 45 mm | In distribution |
| WRS6080-C | Length 80 mm | In distribution |
| WRS5550-TO | Length 50 mm | In distribution |
| WRS6035-T | Outer Diameter 6 mm | In distribution |
| WRC55130-C | Outer Diameter 5.5 mm | In distribution |
| WS7580-N | Length 80 mm | In distribution |
| WS10580-H | Length 80 mm | In distribution |
| WC4755-H | Length 55 mm | In distribution |
| WS5540-N | Length 40 mm | In distribution |
| WS10590-H | Length 90 mm | In distribution |
| WRC5535-C | Length 35 mm | In distribution |
| WRC5570-TO | Outer Diameter 5.5 mm | In distribution |
| WC8580-N | Outer Diameter 8.5 mm | In distribution |
| WRC55300-C | Outer Diameter 5.5 mm | In distribution |
| WRS60120-C | Length 120 mm | In distribution |
| WRS6045-T | Length 45 mm | In distribution |
| WRC5570-T | Outer Diameter 5.5 mm | In distribution |
| WS10545-N | Outer Diameter 10.5 mm | In distribution |
| WRC55140-T | Length 140 mm | In distribution |
| WC8560-H | Outer Diameter 8.5 mm | In distribution |
| WRC5565-C | Outer Diameter 5.5 mm | In distribution |
| WRC5550-TO | Outer Diameter 5.5 mm | In distribution |
| WRC55200-T | Outer Diameter 5.5 mm | In distribution |
| WC8545-H | Length 45 mm | In distribution |
| WRS5575-TO | Length 75 mm | In distribution |
| WRS6060-T | Outer Diameter 6 mm | In distribution |
| WRS55250-TO | Length 250 mm | In distribution |
| WRC6090-C | Length 90 mm | In distribution |
| WS4745-H | Length 45 mm | In distribution |
| WS8555-N | Length 55 mm | In distribution |
| WRC60200-T | Outer Diameter 6 mm | In distribution |
| WC75100-H | Length 100 mm | In distribution |
| WRC6065-C | Length 65 mm | In distribution |
| WS6555-H | Outer Diameter 6.5 mm | In distribution |
| WC7540-H | Length 40 mm | In distribution |
| WRC55140-TO | Length 140 mm | In distribution |
| WC8550-N | Outer Diameter 8.5 mm | In distribution |
| WRC60400-C | Length 400 mm | In distribution |
| WC4740-N | Length 40 mm | In distribution |
| WS10575-H | Outer Diameter 10.5 mm | In distribution |
| WC8535-N | Outer Diameter 8.5 mm | In distribution |
| WRC6080-T | Outer Diameter 6 mm | In distribution |
| WC8530-N | Length 30 mm | In distribution |
| WRC55110-C | Length 110 mm | In distribution |
| WRC60200-C | Outer Diameter 6 mm | In distribution |
| WRS55300-T | Length 300 mm | In distribution |
| WRC60150-T | Outer Diameter 6 mm | In distribution |
| WRS60300-T | Outer Diameter 6 mm | In distribution |
| WS4740-H | Length 40 mm | In distribution |
| WRC55140-C | Length 140 mm | In distribution |
| WRS5555-C | Outer Diameter 5.5 mm | In distribution |
| WRC60500-C | Length 500 mm | In distribution |
| WRC6055-T | Outer Diameter 6 mm | In distribution |
| WC8525-H | Outer Diameter 8.5 mm | In distribution |
| WC7560-H | Length 60 mm | In distribution |
| WRC5545-TO | Outer Diameter 5.5 mm | In distribution |
| WRC5555-C | Outer Diameter 5.5 mm | In distribution |
| WS5555-H | Outer Diameter 5.5 mm | In distribution |
| WC4725-N | Length 25 mm | In distribution |
| WRC5545-C | Length 45 mm | In distribution |
| WS4735-H | Length 35 mm | In distribution |
| WS9550-H | Length 50 mm | In distribution |
| WRC6035-T | Length 35 mm | In distribution |
| WRS6050-T | Length 50 mm | In distribution |
| WRC60500-T | Outer Diameter 6 mm | In distribution |
| WT55-R | Outer Diameter 5.5 mm | In distribution |
| WRC6075-T | Outer Diameter 6 mm | In distribution |
| WRS55500-T | Outer Diameter 5.5 mm | In distribution |
| WS8580-H | Length 80 mm | In distribution |
| WRS60500-C | Outer Diameter 6 mm | In distribution |
| WRC55120-C | Length 120 mm | In distribution |
| WRS55130-T | Length 130 mm | In distribution |
| WRC6060-C | Outer Diameter 6 mm | In distribution |
| WC7550-H | Length 50 mm | In distribution |
| WS10540-H | Outer Diameter 10.5 mm | In distribution |
| WRC55250-TO | Outer Diameter 5.5 mm | In distribution |
| WRS55140-C | Length 140 mm | In distribution |
| WRS55130-C | Outer Diameter 5.5 mm | In distribution |
| WS9535-H | Length 35 mm | In distribution |
| WS7530-H | Length 30 mm | In distribution |
| WRC60110-T | Outer Diameter 6 mm | In distribution |
| WS7545-N | Length 45 mm | In distribution |
| WS8530-H | Length 30 mm | In distribution |
| WC6-S | In distribution | |
| WRS5565-C | Outer Diameter 5.5 mm | In distribution |
| WRS55400-C | Outer Diameter 5.5 mm | In distribution |
| WS7560-H | Length 60 mm | In distribution |
| WRC55250-C | Length 250 mm | In distribution |
| WRC60120-T | Outer Diameter 6 mm | In distribution |
| WS6545-N | Outer Diameter 6.5 mm | In distribution |
| WC5550-H | Length 50 mm | In distribution |
| WRC6080-C | Length 80 mm | In distribution |
| WS7590-H | Outer Diameter 7.5 mm | In distribution |
| WRS6090-T | Length 90 mm | In distribution |
| WRS5555-TO | Outer Diameter 5.5 mm | In distribution |
| WC8555-N | Outer Diameter 8.5 mm | In distribution |
| WS8560-H | Outer Diameter 8.5 mm | In distribution |
| WS9555-N | Outer Diameter 9.5 mm | In distribution |
| WRC55130-T | Outer Diameter 5.5 mm | In distribution |
| WRS6075-T | Outer Diameter 6 mm | In distribution |
| WRS55200-TO | Outer Diameter 5.5 mm | In distribution |
| WRS55500-C | Length 500 mm | In distribution |
| WRC6040-T | Outer Diameter 6 mm | In distribution |
| WS5535-N | Outer Diameter 5.5 mm | In distribution |
| WRS55250-C | Length 250 mm | In distribution |
| WS7550-N | Length 50 mm | In distribution |
| WS6530-H | Outer Diameter 6.5 mm | In distribution |
| WS6560-N | Length 60 mm | In distribution |
| WRC6030-T | Length 30 mm | In distribution |
| WRS60500-T | Outer Diameter 6 mm | In distribution |
| WS8525-N | Outer Diameter 8.5 mm | In distribution |
| WC6545-H | Length 45 mm | In distribution |
| WRS5580-C | Length 80 mm | In distribution |
| WC4745-H | Outer Diameter 4.75 mm | In distribution |
| WS75100-N | Length 100 mm | In distribution |
| WS4755-H | Length 55 mm | In distribution |
| WRC55400-C | Outer Diameter 5.5 mm | In distribution |
| WC4745-N | Length 45 mm | In distribution |
| WRC60100-T | Outer Diameter 6 mm | In distribution |
| WC6535-H | Outer Diameter 6.5 mm | In distribution |
| WRC60250-T | Outer Diameter 6 mm | In distribution |
| WS10545-H | Outer Diameter 10.5 mm | In distribution |
| WRS60120-T | Length 120 mm | In distribution |
| WC8550-H | Outer Diameter 8.5 mm | In distribution |
| WS7570-H | Outer Diameter 7.5 mm | In distribution |
| WC7590-H | Outer Diameter 7.5 mm | In distribution |
| WRC55110-TO | Length 110 mm | In distribution |
| WS8555-H | Outer Diameter 8.5 mm | In distribution |
| WRC6040-C | Outer Diameter 6 mm | In distribution |
| WC7580-N | Length 80 mm | In distribution |
| WS105110-H | Length 110 mm | In distribution |
| WS8550-N | Length 50 mm | In distribution |
| WS7590-N | Outer Diameter 7.5 mm | In distribution |
| WC5535-H | Outer Diameter 5.5 mm | In distribution |
| WC8530-H | Length 30 mm | In distribution |
| WRC55500-T | Outer Diameter 5.5 mm | In distribution |
| WRS5575-T | Outer Diameter 5.5 mm | In distribution |
| WC6530-N | Outer Diameter 6.5 mm | In distribution |
| WRC5575-T | Outer Diameter 5.5 mm | In distribution |
| WRS5570-TO | Outer Diameter 5.5 mm | In distribution |
| WRS55110-TO | Outer Diameter 5.5 mm | In distribution |
| WC8535-H | Outer Diameter 8.5 mm | In distribution |
| WS10560-H | Length 60 mm | In distribution |
| WS6535-N | Length 35 mm | In distribution |
| WC8570-N | Outer Diameter 8.5 mm | In distribution |
| WRS5590-T | Length 90 mm | In distribution |
| WRC5540-C | Length 40 mm | In distribution |
| WRC55100-C | Outer Diameter 5.5 mm | In distribution |
| WRC60140-T | Length 140 mm | In distribution |
| WRS55140-TO | Outer Diameter 5.5 mm | In distribution |
| WRS6065-T | Outer Diameter 6 mm | In distribution |
| WRC55130-TO | Outer Diameter 5.5 mm | In distribution |
| WRS60100-C | Outer Diameter 6 mm | In distribution |
| WRS55150-C | Length 150 mm | In distribution |
| WS9560-H | Outer Diameter 9.5 mm | In distribution |
| WS95120-N | Outer Diameter 9.5 mm | In distribution |
| WRS5530-T | Length 30 mm | In distribution |
| WRS60200-T | Outer Diameter 6 mm | In distribution |
| WS8545-H | Length 45 mm | In distribution |
| WS8540-H | Length 40 mm | In distribution |
| WRS55120-C | Outer Diameter 5.5 mm | In distribution |
| WC7555-N | Length 55 mm | In distribution |
| WS95100-N | Outer Diameter 9.5 mm | In distribution |
| WS10550-H | Outer Diameter 10.5 mm | In distribution |
| WRS60130-C | Length 130 mm | In distribution |
| WS5555-N | Outer Diameter 5.5 mm | In distribution |
| WC6-C | 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 |
|---|---|
| K182478 | 2019-01-15 |
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.