Silverbolt/Mainframe
SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X100
15manufacturers in China registered for this device type
127catalogue numbers in this listing
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 | Choice Spine, LP |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K073245 |
| Record published | 2016-03-24 |
| Record revised | 2025-03-13 (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 |
| Sizes | Outer diameter 4 to 8.5 mm; length 30 to 300 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 200-0696 | curved | In distribution |
| 202-2035 | Outer Diameter 5.5 mm | In distribution |
| 200-0490 | curved | In distribution |
| 202-2235 | Length 35 mm | In distribution |
| 200-0460 | curved | In distribution |
| 200-5140 | Outer Diameter 4.5 mm | In distribution |
| 200-0455 | Length 55 mm | In distribution |
| 200-5360 | Length 60 mm | In distribution |
| 200-5365 | Outer Diameter 5.5 mm | In distribution |
| 200-5735 | Length 35 mm | In distribution |
| 200-0690 | Length 90 mm | In distribution |
| 200-5950 | Length 50 mm | In distribution |
| 200-5640 | Length 40 mm | In distribution |
| 200-2350 | Outer Diameter 7.0 mm | In distribution |
| 200-5945 | Outer Diameter 8.5 mm | In distribution |
| 200-2035 | Outer Diameter 5.5 mm | In distribution |
| 201-2235 | Outer Diameter 6.5 mm | In distribution |
| 200-5350 | Length 50 mm | In distribution |
| 200-2235 | Length 35 mm | In distribution |
| 200-0430 | curved | In distribution |
| 200-0465 | Length 65 mm | In distribution |
| 200-5535 | Length 35 mm | In distribution |
| 200-5560 | Length 60 mm | In distribution |
| 200-0240 | straight | In distribution |
| 200-5340 | Length 40 mm | In distribution |
| 200-0660 | Length 60 mm | In distribution |
| 200-2445 | Outer Diameter 7.5 mm | In distribution |
| 200-2355 | Length 55 mm | In distribution |
| 200-2255 | Length 55 mm | In distribution |
| 200-5740 | Outer Diameter 7.5 mm | In distribution |
| 201-2050 | Outer Diameter 5.5 mm | In distribution |
| 200-2345 | Length 45 mm | In distribution |
| 200-0480 | Length 80 mm | In distribution |
| 200-0630 | curved | In distribution |
| 200-5540 | Outer Diameter 6.5 mm | In distribution |
| 200-5555 | Outer Diameter 6.5 mm | In distribution |
| 200-2050 | Length 50 mm | In distribution |
| 201-0296 | Outer Diameter 5.5 mm | In distribution |
| 200-2270 | Length 70 mm | In distribution |
| 201-0245 | Outer Diameter 5.5 mm | In distribution |
| 202-2045 | Outer Diameter 5.5 mm | In distribution |
| 200-0445 | Length 45 mm | In distribution |
| 200-5355 | Outer Diameter 5.5 mm | In distribution |
| 201-2035 | Outer Diameter 5.5 mm | In distribution |
| 201-0270 | Outer Diameter 5.5 mm | In distribution |
| 200-5750 | Outer Diameter 7.5 mm | In distribution |
| 200-0645 | Length 45 mm | In distribution |
| 200-0297 | Length 300 mm | In distribution |
| 200-0496 | Length 100 mm | In distribution |
| 202-2250 | Outer Diameter 5.5 mm | In distribution |
| 200-2265 | Length 65 mm | In distribution |
| 200-5335 | Outer Diameter 5.5 mm | In distribution |
| 201-0265 | Outer Diameter 5.5 mm | In distribution |
| 200-5040 | Outer Diameter 4.0 mm | In distribution |
| 202-2245 | Length 45 mm | In distribution |
| 200-5565 | Outer Diameter 6.5 mm | In distribution |
| 200-5345 | Outer Diameter 5.5 mm | In distribution |
| 200-2045 | Outer Diameter 5.5 mm | In distribution |
| 202-2050 | Length 50 mm | In distribution |
| 200-5545 | Length 45 mm | In distribution |
| 200-2260 | Outer Diameter 6.5 mm | In distribution |
| 200-0450 | curved | In distribution |
| 200-2440 | Length 40 mm | In distribution |
| 200-2455 | Outer Diameter 7.5 mm | In distribution |
| 200-2240 | Outer Diameter 6.5 mm | In distribution |
| 200-0260 | straight | In distribution |
| 202-2230 | Outer Diameter 5.5 mm | In distribution |
| 200-5645 | Outer Diameter 7.0 mm | In distribution |
| 201-0280 | Outer Diameter 5.5 mm | In distribution |
| 202-2040 | Length 40 mm | In distribution |
| 201-0275 | Outer Diameter 5.5 mm | In distribution |
| 200-2065 | Outer Diameter 5.5 mm | In distribution |
| 200-0250 | Length 50 mm | In distribution |
| 200-5955 | Outer Diameter 8.5 mm | In distribution |
| 201-2335 | Outer Diameter 7.0 mm | In distribution |
| 200-0640 | curved | In distribution |
| 200-0680 | Length 80 mm | In distribution |
| 200-5550 | Outer Diameter 6.5 mm | In distribution |
| 200-0292 | straight | In distribution |
| 201-2245 | Outer Diameter 6.5 mm | In distribution |
| 200-5655 | Outer Diameter 7.0 mm | In distribution |
| 200-5650 | Length 50 mm | In distribution |
| 200-0270 | Length 70 mm | In distribution |
| 200-2450 | Length 50 mm | In distribution |
| 200-0440 | curved | In distribution |
| 200-5635 | Outer Diameter 7.0 mm | In distribution |
| 200-2230 | Length 30 mm | In distribution |
| 200-2340 | Outer Diameter 7.0 mm | In distribution |
| 200-5150 | Outer Diameter 4.5 mm | In distribution |
| 200-5940 | Length 40 mm | In distribution |
| 200-0470 | curved | In distribution |
| 200-2030 | Length 30 mm | In distribution |
| 201-0295 | Outer Diameter 5.5 mm | In distribution |
| 200-0650 | curved | In distribution |
| 200-0675 | curved | In distribution |
| 201-0235 | Outer Diameter 5.5 mm | In distribution |
| 200-2250 | Outer Diameter 6.5 mm | In distribution |
| 200-5935 | Outer Diameter 8.5 mm | In distribution |
| 200-5130 | Outer Diameter 4.5 mm | In distribution |
| 201-2255 | Outer Diameter 6.5 mm | In distribution |
| 200-2275 | Length 75 mm | In distribution |
| 200-0230 | Length 30 mm | In distribution |
| 200-0435 | Length 35 mm | In distribution |
| 200-5330 | Length 30 mm | In distribution |
| 200-2055 | Outer Diameter 5.5 mm | In distribution |
| 200-5160 | Outer Diameter 4.5 mm | In distribution |
| 200-5630 | Length 30 mm | In distribution |
| 202-2240 | Outer Diameter 5.5 mm | In distribution |
| 200-0296 | straight | In distribution |
| 200-0685 | curved | In distribution |
| 200-2040 | Length 40 mm | In distribution |
| 202-2030 | Length 30 mm | In distribution |
| 200-0670 | Length 70 mm | In distribution |
| 200-5745 | Length 45 mm | In distribution |
| 200-5755 | Length 55 mm | In distribution |
| 200-2060 | Outer Diameter 5.5 mm | In distribution |
| 201-0255 | Outer Diameter 5.5 mm | In distribution |
| 200-0665 | curved | In distribution |
| 200-0293 | Length 100 mm | In distribution |
| 201-2345 | Outer Diameter 7.0 mm | In distribution |
| 200-0290 | Length 90 mm | In distribution |
| 201-2355 | Outer Diameter 7.0 mm | In distribution |
| 200-2245 | Length 45 mm | In distribution |
| 200-0280 | straight | In distribution |
| 200-2335 | Length 35 mm | In distribution |
| 200-0635 | Length 35 mm | In distribution |
| 200-2435 | Outer Diameter 7.5 mm | In distribution |
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
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.