Brickyard
Brickyard Standalone Trials, 32x24, 8°, 20mm
14manufacturers in China registered for this device type
311catalogue 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 | 2024-08-29 |
| 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 |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Angle 12 to 25 °; height 13 to 19 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1030-38271618 | In distribution | |
| 1030-32241620 | In distribution | |
| 1030-42301620 | In distribution | |
| 1030-38271615 | In distribution | |
| 1020-32241210 | In distribution | |
| 1020-32242517 | In distribution | |
| 1030-38272012 | In distribution | |
| 1020-42301616 | In distribution | |
| 1020-38270813 | In distribution | |
| 1030-32242518 | In distribution | |
| 1030-42302016 | In distribution | |
| 1020-38271211 | In distribution | |
| 1020-42301615 | Angle 16 ° | In distribution |
| 1030-38271617 | In distribution | |
| 1020-42302015 | Angle 20 ° | In distribution |
| 1030-38271210 | In distribution | |
| 1030-38272520 | In distribution | |
| 1020-34261616 | In distribution | |
| 1030-42300817 | In distribution | |
| 1030-32241217 | In distribution | |
| 1030-32240813 | In distribution | |
| 1020-42301212 | In distribution | |
| 1020-42300810 | In distribution | |
| 1030-32242517 | In distribution | |
| 1030-42301618 | In distribution | |
| 1020-38271616 | In distribution | |
| 1030-38271216 | In distribution | |
| 1030-32241211 | In distribution | |
| 1020-34262515 | In distribution | |
| 1030-38272516 | In distribution | |
| 1030-38270809 | In distribution | |
| 1020-34261215 | In distribution | |
| 1030-32240816 | In distribution | |
| 1020-38271212 | In distribution | |
| 1020-32241616 | In distribution | |
| 1030-38270814 | In distribution | |
| 1030-38272018 | In distribution | |
| 1020-38271214 | In distribution | |
| 1030-32242012 | In distribution | |
| 1020-32241614 | In distribution | |
| 1030-42301212 | In distribution | |
| 1020-38271619 | In distribution | |
| 1030-42301214 | In distribution | |
| 1030-38272519 | In distribution | |
| 1020-38272015 | In distribution | |
| 1030-42302017 | In distribution | |
| 1020-34260812 | In distribution | |
| 1020-38270817 | In distribution | |
| 1030-42301218 | In distribution | |
| 1030-32242015 | In distribution | |
| 1030-38271217 | In distribution | |
| 1020-32240813 | In distribution | |
| 1030-32241612 | In distribution | |
| 1030-32242014 | In distribution | |
| 1020-38271216 | In distribution | |
| 1020-38271210 | In distribution | |
| 1020-34261210 | In distribution | |
| 1030-38272013 | In distribution | |
| 1030-32240809 | In distribution | |
| 1020-32240819 | In distribution | |
| 1020-32241611 | In distribution | |
| 1030-32241212 | In distribution | |
| 1020-38271620 | In distribution | |
| 1030-38272020 | In distribution | |
| 1030-32241218 | In distribution | |
| 1020-32242017 | In distribution | |
| 1020-38272019 | In distribution | |
| 1030-38271220 | In distribution | |
| 1020-34261216 | In distribution | |
| 1020-42302519 | Height 19 mm | In distribution |
| 1030-42302019 | In distribution | |
| 1020-34260815 | In distribution | |
| 1020-32242012 | In distribution | |
| 1020-38272016 | In distribution | |
| 1020-34261211 | In distribution | |
| 1030-42300813 | In distribution | |
| 1020-32241217 | In distribution | |
| 1030-32242019 | In distribution | |
| 1030-42300820 | In distribution | |
| 1030-32241216 | In distribution | |
| 1020-32241218 | In distribution | |
| 1030-38270813 | In distribution | |
| 1030-32240811 | In distribution | |
| 1020-38271217 | In distribution | |
| 1030-38270810 | In distribution | |
| 1020-42302020 | In distribution | |
| 1030-38270819 | In distribution | |
| 1030-38271214 | In distribution | |
| 1020-32241214 | In distribution | |
| 1020-32242518 | In distribution | |
| 1030-42301211 | In distribution | |
| 1020-42302019 | Height 19 mm | In distribution |
| 1020-32242019 | In distribution | |
| 1020-38270816 | In distribution | |
| 1020-34261619 | In distribution | |
| 1030-38270811 | In distribution | |
| 1020-32241215 | In distribution | |
| 1020-42302517 | Height 17 mm | In distribution |
| 1020-34261618 | In distribution | |
| 1020-34262013 | In distribution | |
| 1020-38270814 | In distribution | |
| 1030-38271613 | In distribution | |
| 1020-34261611 | In distribution | |
| 1020-34262519 | In distribution | |
| 1020-32240820 | In distribution | |
| 1030-42301614 | In distribution | |
| 1020-34260820 | In distribution | |
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| 1020-42302520 | In distribution | |
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| 1020-34260817 | In distribution | |
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| 1020-42301218 | In distribution | |
| 1020-42302016 | In distribution | |
| 1030-32241215 | In distribution | |
| 1020-34261217 | In distribution | |
| 1020-32240811 | In distribution | |
| 1030-32242020 | In distribution | |
| 1020-34261218 | In distribution | |
| 1020-42302018 | In distribution | |
| 1020-38271618 | In distribution | |
| 1020-32241619 | In distribution | |
| 1030-38272518 | In distribution | |
| 1020-32242519 | In distribution | |
| 1030-38272014 | In distribution | |
| 1030-42301616 | In distribution | |
| 1020-32242015 | In distribution | |
| 1030-42302018 | In distribution | |
| 1020-42302518 | In distribution | |
| 1020-38271215 | In distribution | |
| 1030-38270817 | In distribution | |
| 1020-42301219 | Height 19 mm | In distribution |
| 1020-32242515 | In distribution | |
| 1020-32240810 | In distribution | |
| 1030-38270818 | In distribution | |
| 1030-38272517 | In distribution | |
| 1020-34261614 | In distribution | |
| 1020-42301220 | In distribution | |
| 1020-32240817 | In distribution | |
| 1020-38271218 | In distribution | |
| 1030-38272017 | In distribution | |
| 1020-38272520 | In distribution | |
| 1020-34262518 | In distribution | |
| 1030-42302520 | In distribution | |
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| 1030-32241619 | In distribution | |
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| 1030-38271619 | In distribution | |
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| 1020-38271213 | In distribution | |
| 1030-38271219 | In distribution | |
| 1030-42300810 | In distribution | |
| 1020-42301217 | Angle 12 ° | In distribution |
| 1020-32240815 | In distribution | |
| 1020-42300818 | In distribution | |
| 1030-42300812 | In distribution | |
| 1020-34261613 | In distribution | |
| 1020-32241209 | In distribution | |
| 1020-32241613 | In distribution | |
| 1020-34262014 | In distribution | |
| 1020-32242018 | In distribution | |
| 1020-38270812 | In distribution | |
| 1030-32241613 | In distribution | |
| 1030-42302519 | In distribution | |
| 1030-32240819 | In distribution | |
| 1020-38271220 | In distribution | |
| 1030-42301615 | In distribution | |
| 1030-42301217 | In distribution | |
| 1020-42301619 | Height 19 mm | In distribution |
| 1020-42301620 | In distribution | |
| 1020-32241211 | In distribution | |
| 1020-38270820 | In distribution | |
| 1020-32241216 | In distribution | |
| 1020-32242020 | In distribution | |
| 1020-38272013 | In distribution | |
| 1030-38271215 | In distribution | |
| 1020-34260808 | In distribution | |
| 1020-38272515 | In distribution | |
| 1030-32241615 | In distribution | |
| 1020-32241615 | In distribution | |
| 1030-32241616 | In distribution | |
| 1030-42301215 | In distribution | |
| 1020-32242013 | In distribution | |
| 1030-32241210 | In distribution | |
| 1020-42301614 | In distribution | |
| 1020-34261220 | In distribution | |
| 1020-42301214 | In distribution | |
| 1020-32242016 | In distribution | |
| 1030-32241220 | In distribution | |
| 1030-42301617 | In distribution | |
| 1020-34262517 | In distribution | |
| 1030-32242520 | In distribution | |
| 1020-38270818 | In distribution | |
| 1020-34261617 | In distribution | |
| 1020-38272018 | In distribution | |
| 1020-38272017 | In distribution | |
| 1030-32241618 | In distribution | |
| 1030-32241617 | In distribution | |
| 1030-32242519 | In distribution | |
| 1020-32240809 | In distribution | |
| 1020-38271615 | In distribution | |
| 1020-38272516 | In distribution | |
| 1020-34262019 | In distribution | |
| 1020-32241618 | In distribution | |
| 1030-32242016 | In distribution | |
| 1020-32241617 | In distribution | |
| 1030-32242516 | In distribution | |
| 1030-42300816 | In distribution | |
| 1030-42300811 | In distribution | |
| 1020-34261214 | In distribution | |
| 1030-38270816 | In distribution | |
| 1020-42301613 | Angle 16 ° | In distribution |
| 1020-38270815 | In distribution | |
| 1020-42301618 | In distribution | |
| 1020-34262016 | In distribution | |
| 1030-32240817 | In distribution | |
| 1030-42301216 | In distribution | |
| 1020-32241612 | In distribution | |
| 1030-42301213 | In distribution | |
| 1030-38272019 | In distribution | |
| 1020-32242514 | In distribution | |
| 1020-38272014 | In distribution | |
| 1030-42301220 | In distribution | |
| 1020-32241620 | In distribution | |
| 1020-38271612 | In distribution | |
| 1030-42301219 | In distribution | |
| 1020-32240814 | In distribution | |
| 1020-34260810 | In distribution | |
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| 1020-34262017 | In distribution | |
| 1030-32241219 | In distribution | |
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| 1020-38271613 | In distribution | |
| 1030-42302517 | In distribution | |
| 1020-32240818 | In distribution | |
| 1030-32240820 | In distribution | |
| 1020-32242014 | In distribution | |
| 1020-42300820 | In distribution | |
| 1020-34260818 | In distribution | |
| 1020-42300812 | In distribution | |
| 1030-42300818 | In distribution | |
| 1020-34261615 | In distribution | |
| 1020-38271614 | In distribution | |
| 1030-42300815 | In distribution | |
| 1020-34262516 | In distribution | |
| 1030-32240812 | 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.