Llif Interbody System
22x55x14mm LLIF Cage 7 Deg Lordotic
14manufacturers in China registered for this device type
90catalogue 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 | Evolution Spine, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-06-12 |
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 |
| Sizes | Height 8 to 16 mm; depth 30 to 55 mm; width 18 to 22 mm; angle 7 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LL07225514 | Angle 7 ° | In distribution |
| LL00184010 | Depth 40 mm | In distribution |
| LL00184008 | Parallel | In distribution |
| LL00184508 | Height 8 mm | In distribution |
| LL07184514 | Height 14 mm | In distribution |
| LL07185014 | Width 18 mm | In distribution |
| LL00183016 | Height 16 mm | In distribution |
| LL00225014 | Depth 50 mm | In distribution |
| LL00225512 | Width 22 mm | In distribution |
| LL07183012 | Height 12 mm | In distribution |
| LL07184010 | Width 18 mm | In distribution |
| LL07224516 | Width 22 mm | In distribution |
| LL00224514 | Parallel | In distribution |
| LL00225016 | Height 16 mm | In distribution |
| LL00184014 | Width 18 mm | In distribution |
| LL00184012 | Width 18 mm | In distribution |
| LL07185012 | Height 12 mm | In distribution |
| LL07224010 | Depth 40 mm | In distribution |
| LL00224016 | Height 16 mm | In distribution |
| LL07225010 | Angle 7 ° | In distribution |
| LL00185010 | Parallel | In distribution |
| LL07184014 | Depth 40 mm | In distribution |
| LL00183510 | Width 18 mm | In distribution |
| LL07184510 | Depth 45 mm | In distribution |
| LL00224012 | Height 12 mm | In distribution |
| LL00185012 | Height 12 mm | In distribution |
| LL00183012 | Depth 30 mm | In distribution |
| LL00183010 | Depth 30 mm | In distribution |
| LL07183510 | Height 10 mm | In distribution |
| LL00185508 | Height 8 mm | In distribution |
| LL07224512 | Height 12 mm | In distribution |
| LL00184512 | Height 12 mm | In distribution |
| LL07184012 | Width 18 mm | In distribution |
| LL00185014 | Depth 50 mm | In distribution |
| LL00184516 | Parallel | In distribution |
| LL00183514 | Depth 35 mm | In distribution |
| LL00224010 | Height 10 mm | In distribution |
| LL07183516 | Width 18 mm | In distribution |
| LL00225516 | Height 16 mm | In distribution |
| LL07225014 | Height 14 mm | In distribution |
| LL07183014 | Depth 30 mm | In distribution |
| LL07185510 | Angle 7 ° | In distribution |
| LL00185510 | Depth 55 mm | In distribution |
| LL07183010 | Angle 7 ° | In distribution |
| LL07184016 | Height 16 mm | In distribution |
| LL00224512 | Height 12 mm | In distribution |
| LL07185016 | Height 16 mm | In distribution |
| LL07185010 | Width 18 mm | In distribution |
| LL07184516 | Height 16 mm | In distribution |
| LL07224510 | Depth 45 mm | In distribution |
| LL07224514 | Height 14 mm | In distribution |
| LL07224016 | Width 22 mm | In distribution |
| LL00185016 | Depth 50 mm | In distribution |
| LL00185512 | Depth 55 mm | In distribution |
| LL00224516 | Depth 45 mm | In distribution |
| LL00185008 | Parallel | In distribution |
| LL00183512 | Depth 35 mm | In distribution |
| LL00224008 | Depth 40 mm | In distribution |
| LL00183508 | Height 8 mm | In distribution |
| LL07185514 | Height 14 mm | In distribution |
| LL07225016 | Angle 7 ° | In distribution |
| LL07225012 | Height 12 mm | In distribution |
| LL07225512 | Depth 55 mm | In distribution |
| LL00185514 | Parallel | In distribution |
| LL07184512 | Depth 45 mm | In distribution |
| LL00183008 | Height 8 mm | In distribution |
| LL00183014 | Depth 30 mm | In distribution |
| LL07183512 | Angle 7 ° | In distribution |
| LL07225516 | Angle 7 ° | In distribution |
| LL07183016 | Height 16 mm | In distribution |
| LL00225008 | Width 22 mm | In distribution |
| LL00225010 | Depth 50 mm | In distribution |
| LL00225514 | Parallel | In distribution |
| LL07225510 | Depth 55 mm | In distribution |
| LL00224014 | Height 14 mm | In distribution |
| LL07185516 | Height 16 mm | In distribution |
| LL00225508 | Width 22 mm | In distribution |
| LL00224510 | Depth 45 mm | In distribution |
| LL00184514 | Height 14 mm | In distribution |
| LL07224012 | Angle 7 ° | In distribution |
| LL07185512 | Height 12 mm | In distribution |
| LL00225012 | Parallel | In distribution |
| LL00224508 | Parallel | In distribution |
| LL07183514 | Height 14 mm | In distribution |
| LL00184016 | Parallel | In distribution |
| LL07224014 | Angle 7 ° | In distribution |
| LL00185516 | Width 18 mm | In distribution |
| LL00225510 | Width 22 mm | In distribution |
| LL00183516 | Height 16 mm | In distribution |
| LL00184510 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160663 | 2016-11-16 |
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.