Concorde
CONCORDE INLINE SPINAL SYSTEM LORDOTIC IMPLANT STRAIGHT 11 x 15 x 25mm, 5 DEGREES
14manufacturers in China registered for this device type
105catalogue numbers in this listing
1510(k) clearance
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K151352 |
| Record published | 2016-04-20 |
| Record revised | 2025-12-23 (version 10) |
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 |
| Distribution end date | 2025-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 187827210 | In distribution | |
| 187827514 | In distribution | |
| 196927010 | In distribution | |
| 187835112 | In distribution | |
| 196927019 | In distribution | |
| 187827408 | In distribution | |
| 187831511 | In distribution | |
| 187835209 | In distribution | |
| 187831110 | In distribution | |
| 187835215 | In distribution | |
| 187831509 | In distribution | |
| 196923511 | In distribution | |
| 187835212 | In distribution | |
| 187831210 | In distribution | |
| 187831111 | In distribution | |
| 187835210 | In distribution | |
| 187823410 | In distribution | |
| 187835111 | In distribution | |
| 187823409 | In distribution | |
| 187831513 | In distribution | |
| 187831209 | In distribution | |
| 187827209 | In distribution | |
| 187827215 | In distribution | |
| 187827110 | In distribution | |
| 187823109 | In distribution | |
| 187831411 | In distribution | |
| 187831113 | In distribution | |
| 196927213 | In distribution | |
| 187823412 | In distribution | |
| 187823508 | In distribution | |
| 187827111 | In distribution | |
| 187827108 | In distribution | |
| 187827409 | In distribution | |
| 187831409 | In distribution | |
| 187823110 | In distribution | |
| 187827114 | In distribution | |
| 187827214 | In distribution | |
| 187831412 | In distribution | |
| 187823215 | In distribution | |
| 187827211 | In distribution | |
| 187823411 | In distribution | |
| 187827414 | In distribution | |
| 187823112 | In distribution | |
| 187831108 | In distribution | |
| 187835213 | In distribution | |
| 187823408 | In distribution | |
| 187827113 | In distribution | |
| 187827415 | In distribution | |
| 187831109 | In distribution | |
| 196923509 | In distribution | |
| 187823212 | In distribution | |
| 187827411 | In distribution | |
| 187823105 | In distribution | |
| 196931009 | Withdrawn | |
| 196923010 | Withdrawn | |
| 187505111 | Withdrawn | |
| 196927712 | Withdrawn | |
| 187821108 | Withdrawn | |
| 187821209 | Withdrawn | |
| 187825109 | Withdrawn | |
| 187825110 | Withdrawn | |
| 187860215 | Withdrawn | |
| 187500109 | Withdrawn | |
| 196931314 | Withdrawn | |
| 196923508 | Withdrawn | |
| 187850212 | Withdrawn | |
| 196931011 | Withdrawn | |
| 187505112 | Withdrawn | |
| 196923213 | Withdrawn | |
| 187850213 | Withdrawn | |
| 187855213 | Withdrawn | |
| 187500107 | Withdrawn | |
| 187850211 | Withdrawn | |
| 187850208 | Withdrawn | |
| 187825111 | Withdrawn | |
| 187835114 | Withdrawn | |
| 196931012 | Withdrawn | |
| 196931310 | Withdrawn | |
| 187825108 | Withdrawn | |
| 187821113 | Withdrawn | |
| 196923011 | Withdrawn | |
| 196931309 | Withdrawn | |
| 187831115 | Withdrawn | |
| 196923613 | Withdrawn | |
| 187860213 | Withdrawn | |
| 187855011 | Withdrawn | |
| 196927713 | Withdrawn | |
| 187860211 | Withdrawn | |
| 187500110 | Withdrawn | |
| 196923612 | Withdrawn | |
| 187505110 | Withdrawn | |
| 196923009 | Withdrawn | |
| 196927011 | Withdrawn | |
| 196923212 | Withdrawn | |
| 187500113 | Withdrawn | |
| 187855013 | Withdrawn | |
| 187850010 | Withdrawn | |
| 187850009 | Withdrawn | |
| 196931010 | Withdrawn | |
| 196931313 | Withdrawn | |
| 187860209 | Withdrawn | |
| 187860013 | Withdrawn | |
| 187500112 | Withdrawn | |
| 196931311 | Withdrawn | |
| 187505108 | Withdrawn |
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 |
|---|---|
| K223688 | 2023-03-08 |
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.