Orio
ORIO-TL PEEK Curved TLIF Symmetrical Cage 11mm Wide, 5 deg. Lordosis, 11 X 11 X 28mm
14manufacturers in China registered for this device type
237catalogue numbers in this listing
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 | Spinecraft LLC, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K090887 |
| Record published | 2015-09-28 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L7309-09-524 | In distribution | |
| L7409-08-822 | In distribution | |
| C7100-45 | In distribution | |
| L7511-10-534 | In distribution | |
| L7309-11-524 | In distribution | |
| A7106-12 | In distribution | |
| L7810-15-034 | In distribution | |
| L7711-09-532 | In distribution | |
| C7100-21 | In distribution | |
| L7711-11-528 | In distribution | |
| L7810-09-026 | In distribution | |
| L7511-14-530 | In distribution | |
| L7109-10-526 | In distribution | |
| L7210-13-032 | In distribution | |
| L7511-11-528 | In distribution | |
| L7711-12-528 | In distribution | |
| L7409-13-826 | In distribution | |
| A7112-14 | In distribution | |
| A7212-16 | In distribution | |
| A7100-12 | In distribution | |
| L7109-10-522 | In distribution | |
| L7409-10-824 | In distribution | |
| A7112-20 | In distribution | |
| L7409-09-826 | In distribution | |
| L7409-13-826 | In distribution | |
| L7109-13-522 | In distribution | |
| L7309-09-526 | In distribution | |
| L7711-14-530 | In distribution | |
| L7810-13-032 | In distribution | |
| L7409-11-822 | In distribution | |
| L7109-10-526 | In distribution | |
| L7511-13-528 | In distribution | |
| C7100-34 | In distribution | |
| C7100-42 | In distribution | |
| A7106-20 | In distribution | |
| A7200-20 | In distribution | |
| L7810-13-030 | In distribution | |
| L7309-11-526 | In distribution | |
| L7409-08-824 | In distribution | |
| L7210-08-028 | In distribution | |
| L7711-08-528 | In distribution | |
| L7711-11-530 | In distribution | |
| C7100-22 | In distribution | |
| L7511-09-534 | In distribution | |
| L7711-12-534 | In distribution | |
| L7711-11-528 | In distribution | |
| A7210-10 | In distribution | |
| L7810-10-026 | In distribution | |
| A7112-16 | In distribution | |
| L7511-10-528 | In distribution | |
| L7109-15-524 | In distribution | |
| L7409-15-826 | In distribution | |
| L7210-11-030 | In distribution | |
| L7409-14-824 | In distribution | |
| C7100-18 | In distribution | |
| A7112-18 | In distribution | |
| L7711-11-532 | In distribution | |
| L7711-08-534 | In distribution | |
| A7100-14 | In distribution | |
| L7109-13-524 | In distribution | |
| L7409-13-822 | In distribution | |
| L7210-15-030 | In distribution | |
| A7206-14 | In distribution | |
| L7511-11-534 | In distribution | |
| L7109-11-526 | In distribution | |
| L7210-14-034 | In distribution | |
| L7810-07-026 | In distribution | |
| A7112-12 | In distribution | |
| L7511-09-534 | In distribution | |
| C7100-48 | In distribution | |
| A7212-14 | In distribution | |
| A7106-10 | In distribution | |
| L7210-10-028 | In distribution | |
| L7109-12-522 | In distribution | |
| C7100-15 | In distribution | |
| L7711-12-530 | In distribution | |
| A7106-16 | In distribution | |
| L7511-10-528 | In distribution | |
| A7112-20 | In distribution | |
| L7511-14-534 | In distribution | |
| L7409-15-822 | In distribution | |
| A7200-16 | In distribution | |
| L7711-13-528 | In distribution | |
| C7100-35 | In distribution | |
| A7100-20 | In distribution | |
| C7100-43 | In distribution | |
| L7810-15-028 | In distribution | |
| L7210-09-028 | In distribution | |
| L7210-11-034 | In distribution | |
| L7810-07-026 | In distribution | |
| L7409-11-826 | In distribution | |
| L7511-08-528 | In distribution | |
| L7711-09-534 | In distribution | |
| A7212-18 | In distribution | |
| L7409-12-824 | In distribution | |
| L7711-13-532 | In distribution | |
| A7200-20 | In distribution | |
| L7711-10-530 | In distribution | |
| L7511-10-532 | In distribution | |
| A7206-14 | In distribution | |
| L7109-14-522 | In distribution | |
| L7810-12-026 | In distribution | |
| C7100-45 | In distribution | |
| L7109-14-524 | In distribution | |
| L7309-09-526 | In distribution | |
| L7210-08-034 | In distribution | |
| L7511-10-530 | In distribution | |
| L7210-10-032 | In distribution | |
| L7109-15-522 | In distribution | |
| L7109-14-522 | In distribution | |
| L7711-09-532 | In distribution | |
| L7511-11-530 | In distribution | |
| L7109-15-524 | In distribution | |
| A7212-20 | In distribution | |
| L7109-09-524 | In distribution | |
| A7106-14 | In distribution | |
| L7109-15-522 | In distribution | |
| L7810-07-030 | In distribution | |
| L7810-10-030 | In distribution | |
| C7100-16 | In distribution | |
| L7511-09-528 | In distribution | |
| L7711-08-534 | In distribution | |
| L7711-11-534 | In distribution | |
| L7210-07-032 | In distribution | |
| C7100-47 | In distribution | |
| A7200-12 | In distribution | |
| A7212-18 | In distribution | |
| L7309-12-526 | In distribution | |
| L7309-09-524 | In distribution | |
| C7100-26 | In distribution | |
| L7711-14-532 | In distribution | |
| L7409-13-824 | In distribution | |
| L7210-15-028 | In distribution | |
| L7810-13-028 | In distribution | |
| L7511-13-534 | In distribution | |
| L7810-15-030 | In distribution | |
| L7810-12-030 | In distribution | |
| C7100-24 | In distribution | |
| A7100-10 | In distribution | |
| L7109-14-526 | In distribution | |
| C7100-44 | In distribution | |
| A7200-18 | In distribution | |
| L7409-10-826 | In distribution | |
| L7109-12-526 | In distribution | |
| C7100-47 | In distribution | |
| L7810-08-034 | In distribution | |
| L7409-12-822 | In distribution | |
| L7810-12-032 | In distribution | |
| L7711-10-532 | In distribution | |
| L7309-10-526 | In distribution | |
| L7409-15-826 | In distribution | |
| C7100-38 | In distribution | |
| L7511-08-530 | In distribution | |
| L7711-08-528 | In distribution | |
| A7112-18 | In distribution | |
| L7511-12-532 | In distribution | |
| L7511-08-534 | In distribution | |
| C7100-42 | In distribution | |
| L7711-11-530 | In distribution | |
| L7711-09-530 | In distribution | |
| L7210-08-032 | In distribution | |
| L7810-11-026 | In distribution | |
| L7810-14-032 | In distribution | |
| L7810-09-030 | In distribution | |
| L7511-14-532 | In distribution | |
| L7810-14-034 | In distribution | |
| A7100-14 | In distribution | |
| A7212-20 | In distribution | |
| C7100-44 | In distribution | |
| L7810-13-034 | In distribution | |
| A7212-12 | In distribution | |
| L7511-11-532 | In distribution | |
| L7409-14-822 | In distribution | |
| L7810-08-026 | In distribution | |
| L7711-10-534 | In distribution | |
| C7100-20 | In distribution | |
| L7810-08-034 | In distribution | |
| L7210-07-030 | In distribution | |
| L7711-09-528 | In distribution | |
| L7109-10-522 | In distribution | |
| C7100-22 | In distribution | |
| A7100-18 | In distribution | |
| C7100-27 | In distribution | |
| L7810-14-032 | In distribution | |
| L7511-08-534 | In distribution | |
| A7200-18 | In distribution | |
| A7206-10 | In distribution | |
| L7810-12-028 | In distribution | |
| C7100-23 | In distribution | |
| L7309-13-524 | In distribution | |
| L7109-11-522 | In distribution | |
| L7711-13-532 | In distribution | |
| L7810-11-028 | In distribution | |
| L7511-11-528 | In distribution | |
| C7100-48 | In distribution | |
| L7711-13-530 | In distribution | |
| L7810-08-030 | In distribution | |
| L7109-07-522 | In distribution | |
| L7511-14-528 | In distribution | |
| L7810-13-030 | In distribution | |
| L7511-11-534 | In distribution | |
| L7109-09-522 | In distribution | |
| L7511-08-532 | In distribution | |
| A7212-12 | In distribution | |
| A7206-16 | In distribution | |
| L7810-13-034 | In distribution | |
| A7206-20 | In distribution | |
| L7109-15-526 | In distribution | |
| L7511-12-528 | In distribution | |
| L7210-10-034 | In distribution | |
| L7109-10-524 | In distribution | |
| A7100-16 | In distribution | |
| L7409-12-826 | In distribution | |
| A7112-10 | In distribution | |
| C7100-41 | In distribution | |
| L7511-09-530 | In distribution | |
| A7106-10 | In distribution | |
| L7409-08-826 | In distribution | |
| A7100-20 | In distribution | |
| L7409-08-824 | In distribution | |
| L7711-12-532 | In distribution | |
| L7409-14-822 | In distribution | |
| L7109-07-524 | In distribution | |
| L7109-07-526 | In distribution | |
| L7711-14-532 | In distribution | |
| L7409-14-824 | In distribution | |
| L7810-12-028 | In distribution | |
| L7711-12-534 | In distribution | |
| L7711-08-532 | In distribution | |
| L7109-08-522 | In distribution | |
| L7511-12-530 | In distribution | |
| L7810-15-034 | In distribution | |
| A7206-18 | In distribution | |
| L7210-10-030 | In distribution | |
| L7810-12-034 | In distribution | |
| L7210-11-028 | In distribution | |
| L7511-13-532 | 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
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.