Imola Titanium Interbody Fusion System
10degree Lateral Interbody Fusion, Titanium Imola - L
14manufacturers in China registered for this device type
200catalogue 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 | Altus Spine, 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) | K170512 |
| Record published | 2017-08-22 |
| Record revised | 2018-07-06 (version 3) |
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, manufacturing date |
| Sizes | Width 18 to 30 mm; length 40 to 60 mm; height 8 to 16 mm; angle 6 to 10 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F12250-16T | Width 22 mm | In distribution |
| F02260-12T | Width 22 mm | In distribution |
| F02240-16T | Height 16 mm | In distribution |
| F11855-10T | Angle 10 ° | In distribution |
| F02655-12T | Length 55 mm | In distribution |
| F03045-08T | Length 45 mm | In distribution |
| F62255-08T | Height 8 mm | In distribution |
| F02650-14T | Width 26 mm | In distribution |
| F61860-08T | Length 60 mm | In distribution |
| F02660-14T | Height 14 mm | In distribution |
| F12650-16T | Width 26 mm | In distribution |
| F11845-16T | Length 45 mm | In distribution |
| F03045-12T | Height 12 mm | In distribution |
| F02640-16T | Width 26 mm | In distribution |
| F62260-08T | Angle 6 ° | In distribution |
| F12660-12T | Angle 10 ° | In distribution |
| F13045-14T | Width 30 mm | In distribution |
| F11845-10T | Angle 10 ° | In distribution |
| F02255-14T | Width 22 mm | In distribution |
| F02260-08T | Height 8 mm | In distribution |
| F11845-14T | Width 18 mm | In distribution |
| F02640-12T | Width 26 mm | In distribution |
| F13055-10T | Height 10 mm | In distribution |
| F63040-08T | Height 8 mm | In distribution |
| F03050-16T | Height 16 mm | In distribution |
| F63055-08T | Height 8 mm | In distribution |
| F01850-14T | Length 50 mm | In distribution |
| F02255-10T | Height 10 mm | In distribution |
| F11840-12T | Width 18 mm | In distribution |
| F12660-14T | Width 26 mm | In distribution |
| F62655-08T | Length 55 mm | In distribution |
| F01850-08T | Width 18 mm | In distribution |
| F13060-16T | Height 16 mm | In distribution |
| F02650-08T | Length 50 mm | In distribution |
| F03060-12T | Height 12 mm | In distribution |
| F62245-08T | Width 22 mm | In distribution |
| F12255-14T | Width 22 mm | In distribution |
| F01850-12T | Height 12 mm | In distribution |
| F02645-16T | Width 26 mm | In distribution |
| F02240-08T | Length 40 mm | In distribution |
| F02240-14T | Height 14 mm | In distribution |
| F03060-14T | Width 30 mm | In distribution |
| F12240-12T | Height 12 mm | In distribution |
| F13050-12T | Height 12 mm | In distribution |
| F01840-14T | Length 40 mm | In distribution |
| F02645-12T | Width 26 mm | In distribution |
| F13050-10T | Height 10 mm | In distribution |
| F12255-10T | Height 10 mm | In distribution |
| F11860-10T | Angle 10 ° | In distribution |
| F01840-12T | Width 18 mm | In distribution |
| F03045-10T | Height 10 mm | In distribution |
| F01860-12T | Length 60 mm | In distribution |
| F01855-10T | Length 55 mm | In distribution |
| F03060-10T | Width 30 mm | In distribution |
| F02655-14T | Width 26 mm | In distribution |
| F11860-12T | Length 60 mm | In distribution |
| F13045-10T | Angle 10 ° | In distribution |
| F12240-16T | Angle 10 ° | In distribution |
| F13050-16T | Height 16 mm | In distribution |
| F13055-14T | Angle 10 ° | In distribution |
| F03050-10T | Length 50 mm | In distribution |
| F12660-10T | Angle 10 ° | In distribution |
| F62640-08T | Angle 6 ° | In distribution |
| F02645-08T | Width 26 mm | In distribution |
| F03055-10T | Height 10 mm | In distribution |
| F13040-12T | Angle 10 ° | In distribution |
| F01845-12T | Length 45 mm | In distribution |
| F03055-14T | Width 30 mm | In distribution |
| F02660-16T | Width 26 mm | In distribution |
| F13040-14T | Width 30 mm | In distribution |
| F01855-12T | Height 12 mm | In distribution |
| F62645-08T | Width 26 mm | In distribution |
| F62650-08T | Angle 6 ° | In distribution |
| F03055-16T | Length 55 mm | In distribution |
| F02255-16T | Height 16 mm | In distribution |
| F02240-10T | Height 10 mm | In distribution |
| F03040-08T | Length 40 mm | In distribution |
| F13045-16T | Angle 10 ° | In distribution |
| F11850-14T | Length 50 mm | In distribution |
| F03055-08T | Width 30 mm | In distribution |
| F01860-16T | Height 16 mm | In distribution |
| F63045-08T | Angle 6 ° | In distribution |
| F11850-12T | Width 18 mm | In distribution |
| F11840-14T | Width 18 mm | In distribution |
| F12645-12T | Width 26 mm | In distribution |
| F12655-10T | Length 55 mm | In distribution |
| F12255-16T | Angle 10 ° | In distribution |
| F12260-10T | Height 10 mm | In distribution |
| F02660-10T | Width 26 mm | In distribution |
| F02655-08T | Width 26 mm | In distribution |
| F61850-08T | Width 18 mm | In distribution |
| F11840-10T | Width 18 mm | In distribution |
| F13040-10T | Angle 10 ° | In distribution |
| F13050-14T | Width 30 mm | In distribution |
| F02645-10T | Length 45 mm | In distribution |
| F12250-14T | Angle 10 ° | In distribution |
| F12640-10T | Width 26 mm | In distribution |
| F02250-08T | Width 22 mm | In distribution |
| F03045-16T | Length 45 mm | In distribution |
| F13040-16T | Angle 10 ° | In distribution |
| F12645-10T | Angle 10 ° | In distribution |
| F03040-16T | Height 16 mm | In distribution |
| F02655-10T | Width 26 mm | In distribution |
| F11850-10T | Height 10 mm | In distribution |
| F01850-10T | Length 50 mm | In distribution |
| F12645-14T | Angle 10 ° | In distribution |
| F12245-10T | Angle 10 ° | In distribution |
| F12655-16T | Angle 10 ° | In distribution |
| F01840-10T | Length 40 mm | In distribution |
| F02250-14T | Height 14 mm | In distribution |
| F01840-16T | Length 40 mm | In distribution |
| F12650-14T | Length 50 mm | In distribution |
| F03055-12T | Height 12 mm | In distribution |
| F01855-16T | Height 16 mm | In distribution |
| F02245-08T | Width 22 mm | In distribution |
| F12655-12T | Height 12 mm | In distribution |
| F13060-12T | Width 30 mm | In distribution |
| F02250-16T | Width 22 mm | In distribution |
| F12660-16T | Angle 10 ° | In distribution |
| F12255-12T | Angle 10 ° | In distribution |
| F12260-12T | Height 12 mm | In distribution |
| F02250-10T | Height 10 mm | In distribution |
| F03040-10T | Width 30 mm | In distribution |
| F02645-14T | Height 14 mm | In distribution |
| F01845-08T | Length 45 mm | In distribution |
| F63060-08T | Angle 6 ° | In distribution |
| F02640-10T | Width 26 mm | In distribution |
| F12655-14T | Width 26 mm | In distribution |
| F02245-12T | Length 45 mm | In distribution |
| F12645-16T | Width 26 mm | In distribution |
| F62240-08T | Length 40 mm | In distribution |
| F02650-12T | Length 50 mm | In distribution |
| F11855-16T | Angle 10 ° | In distribution |
| F12640-12T | Width 26 mm | In distribution |
| F12650-10T | Height 10 mm | In distribution |
| F13045-12T | Angle 10 ° | In distribution |
| F03050-08T | Width 30 mm | In distribution |
| F03040-12T | Length 40 mm | In distribution |
| F03060-08T | Width 30 mm | In distribution |
| F12260-14T | Angle 10 ° | In distribution |
| F01850-16T | Height 16 mm | In distribution |
| F02640-08T | Height 8 mm | In distribution |
| F02255-12T | Height 12 mm | In distribution |
| F13060-14T | Width 30 mm | In distribution |
| F02650-10T | Width 26 mm | In distribution |
| F62660-08T | Width 26 mm | In distribution |
| F01845-10T | Width 18 mm | In distribution |
| F11860-16T | Width 18 mm | In distribution |
| F12245-16T | Angle 10 ° | In distribution |
| F13055-16T | Height 16 mm | In distribution |
| F13055-12T | Height 12 mm | In distribution |
| F12250-10T | Width 22 mm | In distribution |
| F13060-10T | Height 10 mm | In distribution |
| F03060-16T | Height 16 mm | In distribution |
| F02250-12T | Height 12 mm | In distribution |
| F02650-16T | Width 26 mm | In distribution |
| F01845-14T | Width 18 mm | In distribution |
| F12640-14T | Height 14 mm | In distribution |
| F11850-16T | Width 18 mm | In distribution |
| F11840-16T | Angle 10 ° | In distribution |
| F61840-08T | Width 18 mm | In distribution |
| F02245-16T | Length 45 mm | In distribution |
| F02640-14T | Height 14 mm | In distribution |
| F63050-08T | Angle 6 ° | In distribution |
| F01840-08T | Width 18 mm | In distribution |
| F02260-16T | Width 22 mm | In distribution |
| F02260-14T | Height 14 mm | In distribution |
| F02260-10T | Height 10 mm | In distribution |
| F03050-14T | Height 14 mm | In distribution |
| F02245-10T | Height 10 mm | In distribution |
| F01860-14T | Height 14 mm | In distribution |
| F03050-12T | Width 30 mm | In distribution |
| F02660-08T | Height 8 mm | In distribution |
| F01860-08T | Length 60 mm | In distribution |
| F61855-08T | Length 55 mm | In distribution |
| F02245-14T | Width 22 mm | In distribution |
| F12245-12T | Angle 10 ° | In distribution |
| F61845-08T | Width 18 mm | In distribution |
| F12245-14T | Width 22 mm | In distribution |
| F02660-12T | Width 26 mm | In distribution |
| F01845-16T | Height 16 mm | In distribution |
| F11855-12T | Length 55 mm | In distribution |
| F62250-08T | Height 8 mm | In distribution |
| F01855-14T | Width 18 mm | In distribution |
| F01860-10T | Width 18 mm | In distribution |
| F03045-14T | Length 45 mm | In distribution |
| F12650-12T | Angle 10 ° | In distribution |
| F03040-14T | Height 14 mm | In distribution |
| F11845-12T | Angle 10 ° | In distribution |
| F12250-12T | Height 12 mm | In distribution |
| F02255-08T | Length 55 mm | In distribution |
| F01855-08T | Height 8 mm | In distribution |
| F12240-14T | Length 40 mm | In distribution |
| F12240-10T | Width 22 mm | In distribution |
| F12640-16T | Angle 10 ° | In distribution |
| F11855-14T | Angle 10 ° | In distribution |
| F02240-12T | Height 12 mm | In distribution |
| F02655-16T | Height 16 mm | In distribution |
| F12260-16T | Angle 10 ° | In distribution |
| F11860-14T | Width 18 mm | 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.