Indy
34mm x 26mm, 12°, 18mm PEEK Spacer - Brickyard ALIF System
14manufacturers in China registered for this device type
713catalogue 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) | K182406 |
| Record published | 2024-07-22 |
| Record revised | 2024-10-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 9 to 20 mm; angle 8 to 25 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1020-34261618 | In distribution | |
| FA34261220T | In distribution | |
| 1020-34262017 | In distribution | |
| FA32240818T | In distribution | |
| 1030-38271214 | In distribution | |
| FA38270819 | In distribution | |
| FA34261213T | In distribution | |
| FA32241611T | In distribution | |
| 1020-32241211 | In distribution | |
| 1030-32242519 | In distribution | |
| 1020-32241615 | In distribution | |
| 1020-38272015 | In distribution | |
| 1030-32242018 | In distribution | |
| FA38270817 | In distribution | |
| FA42301616T | In distribution | |
| 1030-38271615 | In distribution | |
| 1020-32241219 | In distribution | |
| FA32240820T | In distribution | |
| 1020-34261615 | In distribution | |
| 1030-32241211 | In distribution | |
| 1020-34261611 | In distribution | |
| 1020-32242516 | In distribution | |
| FA34261218 | In distribution | |
| FA38271216 | In distribution | |
| 1030-38271220 | In distribution | |
| 1020-32241617 | In distribution | |
| 1030-38271619 | In distribution | |
| 1030-42302018 | In distribution | |
| 1020-42302519 | Height 19 mm | In distribution |
| FA42300818T | In distribution | |
| FA34262013T | In distribution | |
| 1020-34262518 | In distribution | |
| FA32242020T | In distribution | |
| FA32242017T | In distribution | |
| FA38271220 | In distribution | |
| FA42300816 | In distribution | |
| FA38270820T | In distribution | |
| 1030-38270816 | In distribution | |
| FA42301618 | In distribution | |
| 1020-34261612 | In distribution | |
| 1030-32242012 | In distribution | |
| 1030-38271212 | In distribution | |
| FA42302020T | In distribution | |
| 1020-34262516 | In distribution | |
| FA38270813T | In distribution | |
| FA42301220 | In distribution | |
| 1020-32241614 | In distribution | |
| 1030-32241611 | In distribution | |
| FA32240808T | In distribution | |
| 1030-38272017 | In distribution | |
| FA38271218 | In distribution | |
| FA34262519 | In distribution | |
| FA38272018T | In distribution | |
| 1030-42301213 | In distribution | |
| 1020-38271220 | In distribution | |
| FA32241620 | In distribution | |
| 1020-38271620 | In distribution | |
| 1020-32240819 | In distribution | |
| FA34260810T | In distribution | |
| 1020-38270812 | In distribution | |
| 1020-32240817 | In distribution | |
| 1020-38271211 | In distribution | |
| FA34261216 | In distribution | |
| FA38272517 | In distribution | |
| 1030-32240814 | In distribution | |
| FA32240809 | In distribution | |
| FA34262518 | In distribution | |
| 1020-1210 | In distribution | |
| FA34261210T | In distribution | |
| 1030-38272014 | In distribution | |
| 1020-42300812 | In distribution | |
| FA42301219T | In distribution | |
| 1020-42301613 | Angle 16 ° | In distribution |
| FA32240813 | In distribution | |
| 1030-0020 | Height 20 mm | In distribution |
| FA32241616 | In distribution | |
| FA32241620T | In distribution | |
| FA32240814 | In distribution | |
| FA34261211T | In distribution | |
| FA42300820 | In distribution | |
| FA34260812T | In distribution | |
| FA38272517T | In distribution | |
| FA34261210 | In distribution | |
| FA34262018 | In distribution | |
| 1020-34260814 | In distribution | |
| 1020-34261213 | In distribution | |
| 1030-32240811 | In distribution | |
| 1030-38272515 | In distribution | |
| 1030-42302016 | In distribution | |
| 1030-32242520 | In distribution | |
| 1030-0013 | Height 13 mm | In distribution |
| FA42300815 | In distribution | |
| 1030-42300818 | In distribution | |
| FA34261212 | In distribution | |
| FA42301215 | In distribution | |
| FA34260811T | In distribution | |
| 1030-42301620 | In distribution | |
| FA38271617 | In distribution | |
| 1020-1217 | Height 17 mm | In distribution |
| FA34261216T | In distribution | |
| 1020-34262014 | In distribution | |
| FA32241216 | In distribution | |
| FA38271212 | In distribution | |
| FA38271215T | In distribution | |
| FA42301614 | In distribution | |
| 1020-42301614 | In distribution | |
| 1020-32240809 | In distribution | |
| 1020-38271215 | In distribution | |
| FA42302017 | In distribution | |
| 1030-38272520 | In distribution | |
| 1030-42302519 | In distribution | |
| FA42301215T | In distribution | |
| 1020-42301217 | Angle 12 ° | In distribution |
| 1020-32242018 | In distribution | |
| FA32241211 | In distribution | |
| FA32242015T | In distribution | |
| FA42301214 | In distribution | |
| FA34261615 | In distribution | |
| 1020-1218 | In distribution | |
| FA42302019T | In distribution | |
| FA38270809T | In distribution | |
| 1030-38271620 | In distribution | |
| FA32241612 | In distribution | |
| FA42302520 | In distribution | |
| 1030-32240808 | In distribution | |
| 1020-34261211 | In distribution | |
| 1020-32241216 | In distribution | |
| 1020-32241215 | In distribution | |
| FA34262515 | In distribution | |
| FA34260818T | In distribution | |
| FA32240809T | In distribution | |
| FA42300820T | In distribution | |
| 1020-34260809 | In distribution | |
| 1020-34261210 | In distribution | |
| FA38272014 | In distribution | |
| FA32240811 | In distribution | |
| 1030-0019 | Height 19 mm | In distribution |
| 1030-32241614 | In distribution | |
| FA42300819T | In distribution | |
| 1020-38271614 | In distribution | |
| 1020-32241210 | In distribution | |
| FA38271615 | In distribution | |
| FA34261618 | In distribution | |
| FA38272014T | In distribution | |
| 1020-32242015 | In distribution | |
| 1030-38271617 | In distribution | |
| 1030-32242017 | In distribution | |
| FA38271617T | In distribution | |
| FA42302016 | In distribution | |
| FA32240810T | In distribution | |
| FA32241618 | In distribution | |
| FA38272020 | In distribution | |
| 1020-32240818 | In distribution | |
| 1030-38270814 | In distribution | |
| FA42302015 | In distribution | |
| 1020-32241217 | In distribution | |
| 1030-38271210 | In distribution | |
| FA38272518 | In distribution | |
| FA38271217T | In distribution | |
| 1020-38271219 | In distribution | |
| FA32241615T | In distribution | |
| FA32240819T | In distribution | |
| FA32240817 | In distribution | |
| FA34262017 | In distribution | |
| FA42302017T | In distribution | |
| FA42301618T | In distribution | |
| FA32240812 | In distribution | |
| 1020-32241209 | In distribution | |
| 1020-38272518 | In distribution | |
| FA34261613T | In distribution | |
| FA34262520T | In distribution | |
| 1030-0012 | Height 12 mm | In distribution |
| 1020-42300810 | In distribution | |
| FA32240814T | In distribution | |
| 1020-34261217 | In distribution | |
| FA38272015T | In distribution | |
| 1020-38271616 | In distribution | |
| FA42302019 | In distribution | |
| FA32242014 | In distribution | |
| 1020-32240808 | In distribution | |
| 1020-1213 | Height 13 mm | In distribution |
| FA32241212T | In distribution | |
| 1020-38272519 | Angle 25 ° | In distribution |
| 1020-42301216 | In distribution | |
| FA42300813 | In distribution | |
| 1030-32240817 | In distribution | |
| 1030-42301216 | In distribution | |
| FA38271216T | In distribution | |
| 1030-0017 | Height 17 mm | In distribution |
| 1030-42301217 | In distribution | |
| 1020-32241612 | In distribution | |
| FA42301220T | In distribution | |
| 1020-34261614 | In distribution | |
| FA42300814T | In distribution | |
| 1030-38272517 | In distribution | |
| FA42301614T | In distribution | |
| 1020-34260812 | In distribution | |
| FA32241210T | In distribution | |
| FA34262019 | In distribution | |
| 1020-34262520 | In distribution | |
| 1020-32242519 | In distribution | |
| FA38270815T | In distribution | |
| FA42301616 | In distribution | |
| FA32241611 | In distribution | |
| FA34262516T | In distribution | |
| FA42301211 | In distribution | |
| FA32242019T | In distribution | |
| 1030-38270812 | In distribution | |
| 1030-32240813 | In distribution | |
| FA32242515T | In distribution | |
| FA32241619 FA32241619T | In distribution | |
| FA32242517 | In distribution | |
| FA34261217 | In distribution | |
| 1030-32240809 | In distribution | |
| 1030-32241218 | In distribution | |
| FA34262517 | In distribution | |
| 1030-42300820 | In distribution | |
| FA32242016T | In distribution | |
| 1020-38271615 | In distribution | |
| FA32242520T | In distribution | |
| FA32242012 | In distribution | |
| FA34261620 | In distribution | |
| FA34261614T | In distribution | |
| 1020-42301615 | Angle 16 ° | In distribution |
| 1020-42301617 | Height 17 mm | In distribution |
| FA38270816 | In distribution | |
| FA34261617 | In distribution | |
| FA38271219 | In distribution | |
| 1020-42300819 | Height 19 mm | In distribution |
| FA34261212T | In distribution | |
| 1020-1212 | In distribution | |
| FA38272518T | In distribution | |
| FA38272516T | In distribution | |
| FA42302517T | In distribution | |
| FA38271618 | In distribution | |
| 1020-38272017 | In distribution | |
| FA34262017T | In distribution | |
| FA38271616 | In distribution | |
| FA38271214 | In distribution | |
| FA34261612T | In distribution | |
| 1020-34262016 | In distribution | |
| 1030-32240816 | In distribution | |
| FA34260820T | In distribution | |
| 1020-34261220 | In distribution | |
| FA34261220 | In distribution | |
| 1020-32240815 | In distribution | |
| 1030-38271218 | In distribution | |
| 1020-34261216 | In distribution | |
| 1030-42302020 | In distribution | |
| FA42300811 | In distribution |
Showing 250 of 300 catalogue numbers.
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.