Clydesdale™ Spinal System
Clydesdale Spinal System includes interbody cages and trial components for lumbar fusion. The implanted cage supports the intervertebral space, with a hollow body that accommodates…
Clydesdale Spinal System includes interbody cages and trial components for lumbar fusion. The implanted cage supports the intervertebral space, with a hollow body that accommodates autogenous bone graft.
The cage is made from PEEK and includes tantalum markers. Different widths, heights and lordotic angles provide alternative implant geometries, while trials belong to the associated sizing range.
Listed Item
Instrument X0909752 Clyde 22W 8X50 Trial
Placement and Fixation
Cages can be implanted through a minimally invasive lateral approach and are used with supplemental lumbar fixation. Their graft-containing interbody role is separate from the stabilization provided by the additional fixation system.
14manufacturers in China registered for this device type
818catalogue numbers in this listing
18510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K132897 |
| Record published | 2015-08-21 |
| Record revised | 2024-09-11 (version 7) |
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 |
| Sizes | Length 14 to 60 mm; angle 0 to 18 °; height 8 to 80 mm; outer diameter 8 to 45 mm; width 18 to 60 mm |
| Distribution end date | 2026-01-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2969445 | Outer Diameter 14.0 mm | In distribution |
| X0812626 | Length 40.0 mm | In distribution |
| X0812601 | Height 18.0 mm | In distribution |
| X0812380 | Length 55.0 mm | In distribution |
| 2926840 | Outer Diameter 8.0 mm | In distribution |
| X1009448 | Height 14.0 mm | In distribution |
| X0811342 | Height 12.0 mm | In distribution |
| X0811341 | Width 18.0 mm | In distribution |
| X0812905 | Length 60.0 mm | In distribution |
| X0812644 | Angle 0.0 ° | In distribution |
| 2926860 | Outer Diameter 12.0 mm | In distribution |
| X0812567 | Length 45.0 mm | In distribution |
| 2926440 | Angle 6.0 ° | In distribution |
| X0812637 | Height 20.0 mm | In distribution |
| X0812868 | Angle 12.0 ° | In distribution |
| X0812378 | Angle 8.0 ° | In distribution |
| X0909615 | Width 18.0 mm | In distribution |
| 2988250 | Angle 6.0 ° | In distribution |
| X0812915 | Angle 18.0 ° | In distribution |
| 2926240 | Outer Diameter 12.0 mm | In distribution |
| X0811346 | Angle 8.0 ° | In distribution |
| X0812645 | Angle 0.0 ° | In distribution |
| X0811345 | Width 18.0 mm | In distribution |
| 2969255 | Outer Diameter 12.0 mm | In distribution |
| 2969645 | Length 45.0 mm | In distribution |
| X0811348 | Length 50.0 mm | In distribution |
| 2968045 | Outer Diameter 10.0 mm | In distribution |
| 2969845 | Outer Diameter 8.0 mm | In distribution |
| X0812621 | Height 14.0 mm | In distribution |
| 2989240 | Angle 12.0 ° | In distribution |
| 2922460 | Outer Diameter 14.0 mm | In distribution |
| 2922055 | Outer Diameter 10.0 mm | In distribution |
| X0811332 | Angle 8.0 ° | In distribution |
| 2926260 | Outer Diameter 12.0 mm | In distribution |
| X0812571 | Length 40.0 mm | In distribution |
| X0812593 | Angle 12.0 ° | In distribution |
| X0812384 | Length 50.0 mm | In distribution |
| 2969840 | Length 40.0 mm | In distribution |
| 2969040 | Length 40.0 mm | In distribution |
| X0812638 | Angle 18.0 ° | In distribution |
| X0812839 | Length 55.0 mm | In distribution |
| X0812879 | Angle 12.0 ° | In distribution |
| 2985050 | Length 50.0 mm | In distribution |
| 2988460 | Length 60.0 mm | In distribution |
| 2985255 | Outer Diameter 12.0 mm | In distribution |
| X0812468 | Height 18.0 mm | In distribution |
| 2969245 | Length 45.0 mm | In distribution |
| X0812562 | Angle 8.0 ° | In distribution |
| X1009445 | Height 12.0 mm | In distribution |
| X0812569 | Height 16.0 mm | In distribution |
| X0909606 | Width 18.0 mm | In distribution |
| 2968450 | Outer Diameter 14.0 mm | In distribution |
| 2922440 | Length 40.0 mm | In distribution |
| X1209355 | Outer Diameter 10.0 mm | In distribution |
| X0812869 | Angle 12.0 ° | In distribution |
| 2969055 | Length 55.0 mm | In distribution |
| X0812570 | Height 16.0 mm | In distribution |
| X0909756 | Length 55.0 mm | In distribution |
| 2985850 | Length 50.0 mm | In distribution |
| X0812634 | Height 18.0 mm | In distribution |
| X0909760 | Height 14.0 mm | In distribution |
| X0812595 | Angle 12.0 ° | In distribution |
| X0812481 | Height 20.0 mm | In distribution |
| 2988640 | Outer Diameter 16.0 mm | In distribution |
| 2988445 | Outer Diameter 14.0 mm | In distribution |
| 2926060 | Length 60.0 mm | In distribution |
| 2988055 | Angle 6.0 ° | In distribution |
| X0812862 | Length 45.0 mm | In distribution |
| X0812587 | Height 12.0 mm | In distribution |
| X0812478 | Length 50.0 mm | In distribution |
| X0812830 | Length 60.0 mm | In distribution |
| X0812559 | Height 12.0 mm | In distribution |
| X0812565 | Height 14.0 mm | In distribution |
| X0812903 | Height 16.0 mm | In distribution |
| X0811343 | Length 50.0 mm | In distribution |
| X0812635 | Height 18.0 mm | In distribution |
| 2989055 | Length 55.0 mm | In distribution |
| 2984440 | Outer Diameter 14.0 mm | In distribution |
| X0812835 | Length 60.0 mm | In distribution |
| X0812574 | Height 18.0 mm | In distribution |
| 2968655 | Length 55.0 mm | In distribution |
| 2922455 | Outer Diameter 14.0 mm | In distribution |
| 2989650 | Outer Diameter 16.0 mm | In distribution |
| X0812473 | Length 50.0 mm | In distribution |
| 2926855 | Length 55.0 mm | In distribution |
| X0909754 | Height 10.0 mm | In distribution |
| X1009446 | Height 14.0 mm | In distribution |
| X0812603 | Height 18.0 mm | In distribution |
| 2984640 | Length 40.0 mm | In distribution |
| X0811333 | Height 8.0 mm | In distribution |
| 2926655 | Angle 6.0 ° | In distribution |
| X0812914 | Length 55.0 mm | In distribution |
| 2985655 | Length 55.0 mm | In distribution |
| X0812563 | Angle 8.0 ° | In distribution |
| 2988260 | Angle 6.0 ° | In distribution |
| 2985640 | Outer Diameter 16.0 mm | In distribution |
| 2988660 | Angle 6.0 ° | In distribution |
| 2988850 | Length 50.0 mm | In distribution |
| X0812834 | Length 55.0 mm | In distribution |
| 2989440 | Angle 12.0 ° | In distribution |
| X0812642 | Outer Diameter 18.0 mm | In distribution |
| 2988040 | Length 40.0 mm | In distribution |
| X0811349 | Length 50.0 mm | In distribution |
| 2968845 | Outer Diameter 8.0 mm | In distribution |
| 2988245 | Length 45.0 mm | In distribution |
| 2922250 | Angle 12.0 ° | In distribution |
| 2985055 | Outer Diameter 10.0 mm | In distribution |
| X0812639 | Angle 18.0 ° | In distribution |
| 2942001 | In distribution | |
| X0909607 | Width 18.0 mm | In distribution |
| X0812575 | Length 60.0 mm | In distribution |
| X0812472 | Angle 8.0 ° | In distribution |
| 2969240 | Length 40.0 mm | In distribution |
| X0812647 | Length 40.0 mm | In distribution |
| 2968855 | Outer Diameter 8.0 mm | In distribution |
| X0909757 | Width 22.0 mm | In distribution |
| X0812632 | Angle 18.0 ° | In distribution |
| X0812467 | Angle 8.0 ° | In distribution |
| X1209145 | In distribution | |
| X0812629 | Angle 18.0 ° | In distribution |
| 2984240 | Angle 6.0 ° | In distribution |
| 2985250 | Length 50.0 mm | In distribution |
| X0812867 | Height 14.0 mm | In distribution |
| X1209255 | Length 55.0 mm | In distribution |
| 2968645 | Outer Diameter 16.0 mm | In distribution |
| X0811338 | Width 18.0 mm | In distribution |
| X0812610 | Height 20.0 mm | In distribution |
| 2926460 | Angle 6.0 ° | In distribution |
| X0812607 | Height 20.0 mm | In distribution |
| 2989050 | Outer Diameter 10.0 mm | In distribution |
| X0812592 | Height 14.0 mm | In distribution |
| X0812560 | Angle 8.0 ° | In distribution |
| 2922650 | Outer Diameter 16.0 mm | In distribution |
| X0812382 | Angle 8.0 ° | In distribution |
| 2988050 | Outer Diameter 10.0 mm | In distribution |
| X0909609 | Height 55.0 mm | In distribution |
| 2969450 | Length 50.0 mm | In distribution |
| X0812898 | Angle 18.0 ° | In distribution |
| 2969850 | Length 50.0 mm | In distribution |
| 2988450 | Angle 6.0 ° | In distribution |
| X0812483 | Length 50.0 mm | In distribution |
| X1209345 | Outer Diameter 10.0 mm | In distribution |
| X0812623 | Length 50.0 mm | In distribution |
| X0812873 | Angle 12.0 ° | In distribution |
| X1209245 | Length 45.0 mm | In distribution |
| X0812588 | Height 12.0 mm | In distribution |
| X1209240 | Outer Diameter 8.0 mm | In distribution |
| X0812829 | Outer Diameter 10.0 mm | In distribution |
| X0812377 | Length 40.0 mm | In distribution |
| 2926650 | Length 50.0 mm | In distribution |
| X0812599 | Angle 12.0 ° | In distribution |
| X0812482 | Length 45.0 mm | In distribution |
| 2989655 | Outer Diameter 16.0 mm | In distribution |
| X1209450 | Length 50.0 mm | In distribution |
| 2988860 | Outer Diameter 8.0 mm | In distribution |
| 2926450 | Length 50.0 mm | In distribution |
| 2969860 | Outer Diameter 8.0 mm | In distribution |
| X1209340 | Outer Diameter 10.0 mm | In distribution |
| X0812843 | Height 16.0 mm | In distribution |
| X0812827 | Length 45.0 mm | In distribution |
| 2989445 | Angle 12.0 ° | In distribution |
| 2988045 | Outer Diameter 10.0 mm | In distribution |
| 2989245 | Length 45.0 mm | In distribution |
| X0812608 | Height 20.0 mm | In distribution |
| 2926050 | Outer Diameter 10.0 mm | In distribution |
| X1209445 | Outer Diameter 12.0 mm | In distribution |
| 2968640 | Outer Diameter 16.0 mm | In distribution |
| 2926445 | Angle 6.0 ° | In distribution |
| X1209440 | Length 40.0 mm | In distribution |
| 2984260 | Angle 6.0 ° | In distribution |
| 2969250 | Length 50.0 mm | In distribution |
| X0812552 | Angle 8.0 ° | In distribution |
| X0812628 | Height 16.0 mm | In distribution |
| 2988845 | Angle 6.0 ° | In distribution |
| X0812622 | Height 14.0 mm | In distribution |
| X0909611 | Height 8.0 mm | In distribution |
| X0812828 | Length 50.0 mm | In distribution |
| 2985240 | Outer Diameter 12.0 mm | In distribution |
| 2985845 | Outer Diameter 8.0 mm | In distribution |
| 2922640 | Length 40.0 mm | In distribution |
| X0812586 | Angle 12.0 ° | In distribution |
| 2926645 | Angle 6.0 ° | In distribution |
| X0812597 | Length 45.0 mm | In distribution |
| 2985040 | Angle 0.0 ° | In distribution |
| X0812381 | Angle 8.0 ° | In distribution |
| 2989045 | Length 45.0 mm | In distribution |
| X0812870 | Angle 12.0 ° | In distribution |
| X0812609 | Length 55.0 mm | In distribution |
| X0812480 | Angle 12.0 ° | In distribution |
| 2968050 | Outer Diameter 10.0 mm | In distribution |
| X0812832 | Outer Diameter 12.0 mm | In distribution |
| X0812833 | Length 50.0 mm | In distribution |
| X0811336 | Height 10.0 mm | In distribution |
| X0812779 | Length 55.0 mm | In distribution |
| X1209555 | Outer Diameter 14.0 mm | In distribution |
| X0812624 | Length 55.0 mm | In distribution |
| X0909752 | Length 50.0 mm | In distribution |
| 2969650 | Outer Diameter 16.0 mm | In distribution |
| X0812648 | Outer Diameter 20.0 mm | In distribution |
| 2989260 | Length 60.0 mm | In distribution |
| X0812838 | Length 50.0 mm | In distribution |
| X0812633 | Length 50.0 mm | In distribution |
| 2989460 | Angle 12.0 ° | In distribution |
| X0812484 | Angle 12.0 ° | In distribution |
| X0812636 | Angle 18.0 ° | In distribution |
| 2988655 | Angle 6.0 ° | In distribution |
| X0812566 | Angle 8.0 ° | In distribution |
| X0811353 | Length 50.0 mm | In distribution |
| X0812875 | Length 60.0 mm | In distribution |
| 2922050 | Angle 12.0 ° | In distribution |
| X0812865 | Angle 12.0 ° | In distribution |
| 2989645 | Outer Diameter 16.0 mm | In distribution |
| X0812840 | Angle 8.0 ° | In distribution |
| X0812578 | Height 20.0 mm | In distribution |
| 2926850 | Length 50.0 mm | In distribution |
| X0812600 | Length 60.0 mm | In distribution |
| X0811351 | Height 16.0 mm | In distribution |
| X0812878 | Length 50.0 mm | In distribution |
| X0812555 | Angle 8.0 ° | In distribution |
| X0811344 | Width 18.0 mm | In distribution |
| 2984060 | Length 60.0 mm | In distribution |
| 2926045 | Outer Diameter 10.0 mm | In distribution |
| 2989640 | Angle 12.0 ° | In distribution |
| 2984860 | Length 60.0 mm | In distribution |
| X0812475 | Height 20.0 mm | In distribution |
| X0812627 | Angle 18.0 ° | In distribution |
| 2989060 | Outer Diameter 10.0 mm | In distribution |
| 2985840 | Length 40.0 mm | In distribution |
| X0812902 | Length 45.0 mm | In distribution |
| 2988455 | Angle 6.0 ° | In distribution |
| X0811356 | Width 18.0 mm | In distribution |
| X1209455 | Outer Diameter 12.0 mm | In distribution |
| 2984840 | Angle 6.0 ° | In distribution |
| X0812596 | Height 16.0 mm | In distribution |
| 2985645 | Outer Diameter 16.0 mm | In distribution |
| X0811347 | Angle 8.0 ° | In distribution |
| X0812650 | Outer Diameter 20.0 mm | In distribution |
| X0811335 | Width 18.0 mm | In distribution |
| 2968840 | Length 40.0 mm | In distribution |
| X0812383 | Length 45.0 mm | In distribution |
| 2922655 | Outer Diameter 16.0 mm | In distribution |
| X1009442 | Length 55.0 mm | In distribution |
| 2985440 | Outer Diameter 14.0 mm | In distribution |
| X1209650 | Length 50.0 mm | In distribution |
| X0812643 | Length 45.0 mm | In distribution |
| X0812774 | Angle 18.0 ° | In distribution |
| X0812469 | Length 55.0 mm | In distribution |
| X0812864 | Length 55.0 mm | In distribution |
| X0812606 | Height 20.0 mm | In distribution |
| 2922445 | Angle 12.0 ° | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201267 | 2020-08-26 |
| K172199 | 2017-09-19 |
| K171031 | 2017-07-06 |
| K171468 | 2017-06-13 |
| K132897 | 2013-12-11 |
| K133216 | 2013-11-22 |
| K132700 | 2013-09-26 |
| K123027 | 2013-07-25 |
| K122037 | 2013-03-22 |
| K122591 | 2012-09-18 |
| K111525 | 2011-08-24 |
| K103731 | 2011-07-18 |
| K100175 | 2010-06-02 |
| K094025 | 2010-04-26 |
| K090353 | 2009-09-29 |
| K083026 | 2008-12-29 |
| K082342 | 2008-09-12 |
| K080083 | 2008-04-10 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.