Peridot-EX Expandable Intervertebral Body Fusion System
Peridot-EX is an expandable lumbar interbody fusion implant that adjusts in height and lordotic angle. Its titanium-alloy body has a hollow geometry for packing bone graft between the…
Peridot-EX is an expandable lumbar interbody fusion implant that adjusts in height and lordotic angle. Its titanium-alloy body has a hollow geometry for packing bone graft between the vertebrae.
The system includes machined and additively manufactured titanium-alloy constructions in different lengths and heights. Dedicated instruments are required to insert and adjust the implant.
Fixation and Supply
Autogenous and/or allogeneic graft and supplemental fixation are required. Hyperlordotic implants above 20 degrees require at least anterior supplemental fixation. Implants are single-use and supplied gamma-sterilized or nonsterile for steam sterilization; dedicated instruments are supplied nonsterile.
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 | Gbs Commonwealth Co., Ltd., South Korea |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K232292 |
| Record published | 2023-12-01 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L751-08A8 | In distribution | |
| L751-0850 | In distribution | |
| L711-8161 | In distribution | |
| L742-6901 | In distribution | |
| L723-0121 | In distribution | |
| L722-0121S | In distribution | |
| L741-8242S | In distribution | |
| L751-02B0S | In distribution | |
| L751-8251S | In distribution | |
| L712-0161 | In distribution | |
| L741-B244 | In distribution | |
| L723-0121S | In distribution | |
| L751-0858 | In distribution | |
| L741-8904 | In distribution | |
| L721-8129 | In distribution | |
| L712-0069S | In distribution | |
| L751-02A8S | In distribution | |
| L722-0121 | In distribution | |
| L751-0250 | In distribution | |
| L742-6901S | In distribution | |
| L751-0258S | In distribution | |
| L741-B902 | In distribution | |
| L751-8253S | In distribution | |
| L751-08A0 | In distribution | |
| L712-0069 | In distribution | |
| L721-8129S | In distribution | |
| L741-8244S | In distribution | |
| L741-B902S | In distribution | |
| L751-02B0 | In distribution | |
| L751-88B2S | In distribution | |
| L711-8169 | In distribution | |
| L751-8852 | In distribution | |
| L712-0061S | In distribution | |
| L751-82B1 | In distribution | |
| L751-82A1S | In distribution | |
| L714-0169S | In distribution | |
| L742-6249S | In distribution | |
| L712-0161S | In distribution | |
| L751-88A2S | In distribution | |
| L741-8242 | In distribution | |
| L742-6241 | In distribution | |
| L751-88A2 | In distribution | |
| L751-02A8 | In distribution | |
| L742-6241S | In distribution | |
| L741-B904 | In distribution | |
| L711-8169S | In distribution | |
| L742-6909 | In distribution | |
| L751-0858S | In distribution | |
| L751-02A0 | In distribution | |
| L741-B242S | In distribution | |
| L741-8902 | In distribution | |
| L751-82B3S | In distribution | |
| L751-0850S | In distribution | |
| L751-08B0 | In distribution | |
| L721-8121S | In distribution | |
| L723-0129S | In distribution | |
| L741-8902S | In distribution | |
| L751-08A0S | In distribution | |
| L721-8121 | In distribution | |
| L751-8850S | In distribution | |
| L751-02B8S | In distribution | |
| L751-82B1S | In distribution | |
| L712-0169S | In distribution | |
| L722-0029 | In distribution | |
| L751-82A1 | In distribution | |
| L751-0250S | In distribution | |
| L741-B244S | In distribution | |
| L751-8852S | In distribution | |
| L722-0021S | In distribution | |
| L751-08B0S | In distribution | |
| L714-0161S | In distribution | |
| L751-02A0S | In distribution | |
| L751-08A8S | In distribution | |
| L711-8161S | In distribution | |
| L751-82A3 | In distribution | |
| L751-8251 | In distribution | |
| L751-02B8 | In distribution | |
| L741-8904S | In distribution | |
| L751-8850 | In distribution | |
| L751-88B2 | In distribution | |
| L751-88B0 | In distribution | |
| L751-82A3S | In distribution | |
| L751-08B8 | In distribution | |
| L712-0169 | In distribution | |
| L751-88A0 | In distribution | |
| L712-0061 | In distribution | |
| L751-88B0S | In distribution | |
| L741-B242 | In distribution | |
| L751-8253 | In distribution | |
| L741-8244 | In distribution | |
| L751-0258 | In distribution | |
| L722-0129S | In distribution | |
| L714-0169 | In distribution | |
| L722-0029S | In distribution | |
| L751-88A0S | In distribution | |
| L722-0021 | In distribution | |
| L741-B904S | In distribution | |
| L722-0129 | In distribution | |
| L751-08B8S | In distribution | |
| L751-82B3 | In distribution | |
| L714-0161 | In distribution | |
| L723-0129 | In distribution | |
| L742-6249 | In distribution | |
| L742-6909S | In distribution |
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 |
|---|---|
| K232292 | 2023-11-07 |
| K192026 | 2019-11-26 |
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.