Indy Standalone
PEEK/Titanium Interbody, 12 degree, 38mm x 27mm
3manufacturers in China registered for this device type
263catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Altus Spine, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K211837 |
| Record published | 2024-08-09 |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SL32240813T | In distribution | |
| SL32242013T | In distribution | |
| SL32241214 | In distribution | |
| SL38270815 | In distribution | |
| SL32242014 | In distribution | |
| SL42302020 | In distribution | |
| SL32242020 | In distribution | |
| SL42300813T | In distribution | |
| SL32242018 | In distribution | |
| SL32240817 | In distribution | |
| SL38271613T | In distribution | |
| SL42301615 | In distribution | |
| SL38270818T | In distribution | |
| SL32241216T | In distribution | |
| SL32241618T | In distribution | |
| SL42300820T | In distribution | |
| SL32241218T | In distribution | |
| SL32242517T | In distribution | |
| SL42301212 | In distribution | |
| SL42302019 | In distribution | |
| SL42301220 | In distribution | |
| SL38271612 | In distribution | |
| SL32241615 | In distribution | |
| SL42300813 | In distribution | |
| SL38271612T | In distribution | |
| SL0016 | In distribution | |
| 1030-0001 | In distribution | |
| SL38270811T | In distribution | |
| SL32241618 | In distribution | |
| SL42300812T | In distribution | |
| SL42302019T | In distribution | |
| SL32240816T | In distribution | |
| SL42301214 | In distribution | |
| SL32240815T | In distribution | |
| SL32242016 | In distribution | |
| SL32241615T | In distribution | |
| SL42302520T | In distribution | |
| SL38271217T | In distribution | |
| SL32241619T | In distribution | |
| SL32240820 | In distribution | |
| SL38272014T | In distribution | |
| SL32242516T | In distribution | |
| SL32242515T | In distribution | |
| SL38271213 | In distribution | |
| SL38271213T | In distribution | |
| SL38271219 | In distribution | |
| SL38272020 | In distribution | |
| SL38272517T | In distribution | |
| SL42301613T | In distribution | |
| SL32241616 | In distribution | |
| SL38270819T | In distribution | |
| SL38271616T | In distribution | |
| SL42302520 | In distribution | |
| SL38270816 | In distribution | |
| SL42301613 | In distribution | |
| SL32242017T | In distribution | |
| SL42301217T | In distribution | |
| SL0020 | In distribution | |
| SL42300820 | In distribution | |
| SL32241612 | In distribution | |
| SL42300814T | In distribution | |
| SL32241216 | In distribution | |
| SL0015 | In distribution | |
| SL38272016T | In distribution | |
| SL38272017 | In distribution | |
| SL38271615T | In distribution | |
| SL38271220 | In distribution | |
| SL42301619T | In distribution | |
| SL38272517 | In distribution | |
| SL42302518T | In distribution | |
| SL42300815T | In distribution | |
| SL32242518T | In distribution | |
| SL42301217 | In distribution | |
| SL38271212T | In distribution | |
| SL32240816 | In distribution | |
| SL32241219T | In distribution | |
| SL38270816T | In distribution | |
| SL0019 | In distribution | |
| SL42301212T | In distribution | |
| SL42301216T | In distribution | |
| SL42302018T | In distribution | |
| SL38272516 | In distribution | |
| SL32242015 | In distribution | |
| SL42301618 | In distribution | |
| SL42301614 | In distribution | |
| SL38272018T | In distribution | |
| SL32242012T | In distribution | |
| SL32240819 | In distribution | |
| SL32242520T | In distribution | |
| SL32242020T | In distribution | |
| SL32241218 | In distribution | |
| SL42300819T | In distribution | |
| SL38270814T | In distribution | |
| SL42302519 | In distribution | |
| SL42302018 | In distribution | |
| SL38270812T | In distribution | |
| SL32242019T | In distribution | |
| SL38271211 | In distribution | |
| SL42300811T | In distribution | |
| SL32241613 | In distribution | |
| SL32242514T | In distribution | |
| SL32241211T | In distribution | |
| SL38271218T | In distribution | |
| SL38271618 | In distribution | |
| SL32242517 | In distribution | |
| SL42301620 | In distribution | |
| SL0017 | In distribution | |
| SL32241215 | In distribution | |
| SL42301211T | In distribution | |
| SL38270815T | In distribution | |
| SL32241616T | In distribution | |
| SL42302016T | In distribution | |
| SL32242015T | In distribution | |
| SL38270813T | In distribution | |
| SL0018 | In distribution | |
| SL38272015 | In distribution | |
| SL38271211T | In distribution | |
| SL32241611T | In distribution | |
| SL32240812T | In distribution | |
| SL38270814 | In distribution | |
| SL32242017 | In distribution | |
| SL32241217 | In distribution | |
| SL42302519T | In distribution | |
| SL38272016 | In distribution | |
| SL42302015 | In distribution | |
| SL32241620T | In distribution | |
| SL32242012 | In distribution | |
| SL38272516T | In distribution | |
| SL38272020T | In distribution | |
| SL38271217 | In distribution | |
| SL32240812 | In distribution | |
| SL38271620T | In distribution | |
| SL38272013 | In distribution | |
| SL32241213 | In distribution | |
| SL42300817 | In distribution | |
| SL38272018 | In distribution | |
| SL38270817T | In distribution | |
| SL0013 | In distribution | |
| SL32241212 | In distribution | |
| SL38271614 | In distribution | |
| SL32240814T | In distribution | |
| SL32241614 | In distribution | |
| SL38271620 | In distribution | |
| SL38271613 | In distribution | |
| SL32241217T | In distribution | |
| SL42301620T | In distribution | |
| SL42301617T | In distribution | |
| SL32241614T | In distribution | |
| SL38272515 | In distribution | |
| SL38271616 | In distribution | |
| SL32240819T | In distribution | |
| SL38271216T | In distribution | |
| SL32242519T | In distribution | |
| SL38271218 | In distribution | |
| SL32242019 | In distribution | |
| SL32240817T | In distribution | |
| SL42302020T | In distribution | |
| SL42300812 | In distribution | |
| SL32241213T | In distribution | |
| SL42301219 | In distribution | |
| SL38270820T | In distribution | |
| SL38272019T | In distribution | |
| SL38272518 | In distribution | |
| SL32242518 | In distribution | |
| SL38270819 | In distribution | |
| SL42301616 | In distribution | |
| SL32240811 | In distribution | |
| SL38270812 | In distribution | |
| SL38270811 | In distribution | |
| SL38272520T | In distribution | |
| SL32241214T | In distribution | |
| SL38270817 | In distribution | |
| SL42302016 | In distribution | |
| SL32240814 | In distribution | |
| SL38272515T | In distribution | |
| SL38271214T | In distribution | |
| SL42302017T | In distribution | |
| SL32241215T | In distribution | |
| SL32241612T | In distribution | |
| SL32240818 | In distribution | |
| SL38272019 | In distribution | |
| SL32242519 | In distribution | |
| SL32241617T | In distribution | |
| SL32242016T | In distribution | |
| SL38271220T | In distribution | |
| SL42300819 | In distribution | |
| SL42301214T | In distribution | |
| SL38272014 | In distribution | |
| SL32242018T | In distribution | |
| SL42301215T | In distribution | |
| SL38270818 | In distribution | |
| SL32241611 | In distribution | |
| SL42302517 | In distribution | |
| SL42301218 | In distribution | |
| SL32242014T | In distribution | |
| SL32241212T | In distribution | |
| SL38272518T | In distribution | |
| SL32240811T | In distribution | |
| SL32242520 | In distribution | |
| SL32240820T | In distribution | |
| SL32241619 | In distribution | |
| SL42301618T | In distribution | |
| SL42302517T | In distribution | |
| SL38271212 | In distribution | |
| SL42301614T | In distribution | |
| SL42300815 | In distribution | |
| SL42300817T | In distribution | |
| SL42300816 | In distribution | |
| SL42300816T | In distribution | |
| SL32240815 | In distribution | |
| SL38271215T | In distribution | |
| SL38271216 | In distribution | |
| SL42302017 | In distribution | |
| SL42301615T | In distribution | |
| SL42301215 | In distribution | |
| SL38271214 | In distribution | |
| SL42301213T | In distribution | |
| SL38270820 | In distribution | |
| SL42300811 | In distribution | |
| SL42301619 | In distribution | |
| SL38272519T | In distribution | |
| SL42300814 | In distribution | |
| SL38271617 | In distribution | |
| SL38271619 | In distribution | |
| SL32240813 | In distribution | |
| SL32241613T | In distribution | |
| SL38271619T | In distribution | |
| SL32242514 | In distribution | |
| SL32241620 | In distribution | |
| SL38271618T | In distribution | |
| SL38271617T | In distribution | |
| SL42301617 | In distribution | |
| SL32241219 | In distribution | |
| SL38272017T | In distribution | |
| SL42301616T | In distribution | |
| SL32242516 | In distribution | |
| SL42301211 | In distribution | |
| SL38271215 | In distribution | |
| SL32241211 | In distribution | |
| SL32240818T | In distribution | |
| SL42301218T | In distribution | |
| SL42302015T | In distribution | |
| SL32242515 | In distribution | |
| SL38272519 | In distribution | |
| SL32241220 | In distribution | |
| SL38272520 | In distribution | |
| SL38271615 | In distribution | |
| SL32241617 | In distribution | |
| SL38271614T | In distribution | |
| SL38271219T | In distribution |
Showing 250 of 263 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
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.