Expedium
EXPEDIUM SPINE SYSTEM SLOTTED CONNECTOR FOR POLYAXIAL BOLT, OFFSET LEFT 5.5/6.35mm
15manufacturers in China registered for this device type
324catalogue 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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K033901 |
| Record published | 2015-09-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
| Distribution end date | 2024-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 179702435 | In distribution | |
| 188115520 | In distribution | |
| 179972045 | In distribution | |
| 175450320 | In distribution | |
| 179988630 | In distribution | |
| 179722940 | In distribution | |
| 179784150 | In distribution | |
| 179762075 | In distribution | |
| 188115550 | In distribution | |
| 179712625 | In distribution | |
| 189663163 | In distribution | |
| 179722960 | In distribution | |
| 179722050 | In distribution | |
| 175412640 | In distribution | |
| 179788435 | In distribution | |
| 175422745 | In distribution | |
| 179998025 | In distribution | |
| 175422530 | In distribution | |
| 179912801 | In distribution | |
| 175460060 | In distribution | |
| 179970075 | In distribution | |
| 179772095S | In distribution | |
| 179788765 | In distribution | |
| 179771090 | In distribution | |
| 179732650 | In distribution | |
| 179941100 | In distribution | |
| 179777065 | In distribution | |
| 179702645 | In distribution | |
| 179783750 | In distribution | |
| 179722440 | In distribution | |
| 179970600 | In distribution | |
| 179752090 | In distribution | |
| 179988435 | In distribution | |
| 175450032 | In distribution | |
| 179732430 | In distribution | |
| 175491040 | In distribution | |
| 175455032 | In distribution | |
| 175412845 | In distribution | |
| 179794150 | In distribution | |
| 179772055S | In distribution | |
| 179771030 | In distribution | |
| 179912880 | In distribution | |
| 179715650 | In distribution | |
| 179702445 | In distribution | |
| 179732525 | In distribution | |
| 179912935 | In distribution | |
| 179722865 | In distribution | |
| 179722935 | In distribution | |
| 175491150 | In distribution | |
| 179794200 | In distribution | |
| 179912885 | In distribution | |
| 175432840 | In distribution | |
| 175450050 | In distribution | |
| 179942046 | In distribution | |
| 175432745 | In distribution | |
| 179902655 | In distribution | |
| 186178600 | In distribution | |
| 179712090 | In distribution | |
| 179912655 | In distribution | |
| 179712399 | In distribution | |
| 187722647 | In distribution | |
| 175461010 | In distribution | |
| 179722545 | In distribution | |
| 179722945 | In distribution | |
| 179771135 | In distribution | |
| 179777300 | In distribution | |
| 179970090 | In distribution | |
| 179777075 | In distribution | |
| 179980300 | In distribution | |
| 175432730 | In distribution | |
| 175450015 | In distribution | |
| 188161024 | In distribution | |
| 179997025 | In distribution | |
| 179912902 | In distribution | |
| 179793150 | In distribution | |
| 179752200 | In distribution | |
| 175412735 | In distribution | |
| 179712040 | In distribution | |
| 175412730 | In distribution | |
| 189662512 | In distribution | |
| 179797200 | In distribution | |
| 189662075 | In distribution | |
| 175432535 | In distribution | |
| 179912845 | In distribution | |
| 179722630 | In distribution | |
| 188197040 | In distribution | |
| 179712995 | In distribution | |
| 179712080 | In distribution | |
| 179963300 | In distribution | |
| 179919965 | In distribution | |
| 179932745 | In distribution | |
| 175455300 | In distribution | |
| 179712620 | In distribution | |
| 175461000 | In distribution | |
| 179706090 | In distribution | |
| 179752012 | In distribution | |
| 179902650 | In distribution | |
| 179715635 | In distribution | |
| 179712755S | In distribution | |
| 189662513 | In distribution | |
| 179784105 | In distribution | |
| 179712535 | In distribution | |
| 179941020 | In distribution | |
| 175422945 | In distribution | |
| 179702835 | In distribution | |
| 188162513 | In distribution | |
| 179702760 | In distribution | |
| 179932530 | In distribution | |
| 179712050 | In distribution | |
| 188169512 | In distribution | |
| 179702630 | In distribution | |
| 179712540 | In distribution | |
| 179912085 | In distribution | |
| 179700080 | In distribution | |
| 179712555 | In distribution | |
| 175462935 | In distribution | |
| 179702000S | In distribution | |
| 196791455 | In distribution | |
| 179752265 | In distribution | |
| 179722840 | In distribution | |
| 179783640 | In distribution | |
| 186162382 | In distribution | |
| 175422040 | In distribution | |
| 175460100 | In distribution | |
| 179932535 | In distribution | |
| 189662055 | In distribution | |
| 179932650 | In distribution | |
| 175422750 | In distribution | |
| 179952035 | In distribution | |
| 179771080 | In distribution | |
| 179952029 | In distribution | |
| 179712770 | In distribution | |
| 179706065 | In distribution | |
| 175430025 | In distribution | |
| 179712045 | In distribution | |
| 179712870 | In distribution | |
| 175412935 | In distribution | |
| 175430060 | In distribution | |
| 179772035S | In distribution | |
| 179997060 | In distribution | |
| 186178300 | In distribution | |
| 179752111 | In distribution | |
| 179988650 | In distribution | |
| 175422940 | In distribution | |
| 179722155 | In distribution | |
| 196791320 | In distribution | |
| 188169513 | In distribution | |
| 179797025 | In distribution | |
| 179970065 | In distribution | |
| 179732445 | In distribution | |
| 175412040 | In distribution | |
| 189662045 | In distribution | |
| 179912940 | In distribution | |
| 179752060 | In distribution | |
| 175422880 | In distribution | |
| 179970095 | In distribution | |
| 179932735 | In distribution | |
| 179712170 | In distribution | |
| 179912260 | In distribution | |
| 175430635 | In distribution | |
| 196791385 | In distribution | |
| 175461005 | In distribution | |
| 179902525 | In distribution | |
| 179772040S | In distribution | |
| 175462940 | In distribution | |
| 189662085 | In distribution | |
| 179718870 | In distribution | |
| 175412645 | In distribution | |
| 189667600 | In distribution | |
| 186189380S | In distribution | |
| 175460010 | In distribution | |
| 179702635 | In distribution | |
| 175430100 | In distribution | |
| 175422655 | In distribution | |
| 188162502 | In distribution | |
| 179912802 | In distribution | |
| 179942041 | In distribution | |
| 179752295 | In distribution | |
| 179919090 | In distribution | |
| 179732760 | In distribution | |
| 179788625 | In distribution | |
| 175422640 | In distribution | |
| 179715640 | In distribution | |
| 179952036 | In distribution | |
| 179970035 | In distribution | |
| 179970080 | In distribution | |
| 179752211 | In distribution | |
| 179988755 | In distribution | |
| 179712635 | In distribution | |
| 179712350 | In distribution | |
| 179932445 | In distribution | |
| 175422730 | In distribution | |
| 179771040 | In distribution | |
| 179722995 | In distribution | |
| 188162512 | In distribution | |
| 179762120 | In distribution | |
| 175422980 | In distribution | |
| 179988525 | In distribution | |
| 179972095 | In distribution | |
| 179718780 | In distribution | |
| 179702535 | In distribution | |
| 179912990 | In distribution | |
| 179712250 | In distribution | |
| 179902755 | In distribution | |
| 179715535 | In distribution | |
| 175426880 | In distribution | |
| 179912950 | In distribution | |
| 179712740S | In distribution | |
| 179798030 | In distribution | |
| 188152095 | In distribution | |
| 179789383 | In distribution | |
| 179712175 | In distribution | |
| 188165255 | In distribution | |
| 179902530 | In distribution | |
| 188140001 | In distribution | |
| 179719780 | In distribution | |
| 179784135 | In distribution | |
| 179712160 | In distribution | |
| 179719770 | In distribution | |
| 175443038 | In distribution | |
| 179712180 | In distribution | |
| 189632550 | Withdrawn | |
| 189602640 | Withdrawn | |
| 189652150 | Withdrawn | |
| 188152029 | Withdrawn | |
| 189612675 | Withdrawn | |
| 185422530 | Withdrawn | |
| 188112180 | Withdrawn | |
| 179915650 | Withdrawn | |
| 188122850 | Withdrawn | |
| 185455030 | Withdrawn | |
| 179972050 | Withdrawn | |
| 185460010 | Withdrawn | |
| 189652015 | Withdrawn | |
| 188188745 | Withdrawn | |
| 189632735 | Withdrawn | |
| 175450550 | Withdrawn | |
| 185443036 | Withdrawn | |
| 189652100 | Withdrawn | |
| 185422655 | Withdrawn | |
| 175426990 | Withdrawn | |
| 189602730 | Withdrawn | |
| 185417655 | Withdrawn | |
| 189612635 | Withdrawn | |
| 188122160 | Withdrawn | |
| 179799735 | Withdrawn | |
| 185412640 | Withdrawn | |
| 189652028 | Withdrawn | |
| 179799625 | Withdrawn | |
| 179799760 | 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 |
|---|---|
| K200245 | 2020-04-24 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Spine, Inc. | 510(k) number | 2015-04-21 | Class II | Process design | Device does not mate as intended. | 183 devices | 2018-10-03 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 34 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 36 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 2013-12-24 | |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 24 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 34 uits | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 23 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 6 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head. | 10 units | 2013-12-24 |
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.