Aero-LL
Lumbar Cage System
3manufacturers in China registered for this device type
61catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2025-07-14 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 40 to 60 mm; height 8 to 16 mm; width 18 to 22 mm; angle 0 to 8 ° |
| Distribution end date | 2024-11-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48944012 | Height 12.0 mm | In distribution |
| 48944014 | Height 14.0 mm | In distribution |
| 48945012 | Height 12.0 mm | In distribution |
| 48943314 | Length 55.0 mm | Withdrawn |
| 48942408 | Width 22.0 mm | Withdrawn |
| 48943110 | Height 10.0 mm | Withdrawn |
| 48943014 | Height 14.0 mm | Withdrawn |
| 48942216 | Length 50.0 mm | Withdrawn |
| 48943112 | Height 12.0 mm | Withdrawn |
| 48941010 | Angle 8.0 ° | Withdrawn |
| 48940050 | Length 50.0 mm | Withdrawn |
| 48942312 | Height 12.0 mm | Withdrawn |
| 48941114 | Height 14.0 mm | Withdrawn |
| 48943114 | Width 22.0 mm | Withdrawn |
| 48940045 | Length 45.0 mm | Withdrawn |
| 48940308 | Height 8.0 mm | Withdrawn |
| 48942008 | Angle 0.0 ° | Withdrawn |
| 48941112 | Angle 8.0 ° | Withdrawn |
| 48940012 | Height 12.0 mm | Withdrawn |
| 48940210 | Width 18.0 mm | Withdrawn |
| 48940010 | Length 40.0 mm | Withdrawn |
| 48940216 | Height 16.0 mm | Withdrawn |
| 48942010 | Length 40.0 mm | Withdrawn |
| 48940108 | Height 8.0 mm | Withdrawn |
| 48940060 | Length 60.0 mm | Withdrawn |
| 48941312 | Angle 8.0 ° | Withdrawn |
| 48940310 | Length 55.0 mm | Withdrawn |
| 48943412 | Angle 8.0 ° | Withdrawn |
| 48943016 | Width 22.0 mm | Withdrawn |
| 48943012 | Angle 8.0 ° | Withdrawn |
| 48942108 | Width 22.0 mm | Withdrawn |
| 48943316 | Angle 8.0 ° | Withdrawn |
| 48940416 | Angle 0.0 ° | Withdrawn |
| 48941216 | Angle 8.0 ° | Withdrawn |
| 48942210 | Height 10.0 mm | Withdrawn |
| 48941210 | Height 10.0 mm | Withdrawn |
| 48940314 | Width 18.0 mm | Withdrawn |
| 48940112 | Width 18.0 mm | Withdrawn |
| 48942410 | Length 60.0 mm | Withdrawn |
| 48942316 | Height 16.0 mm | Withdrawn |
| 48940114 | Height 14.0 mm | Withdrawn |
| 48941110 | Length 45.0 mm | Withdrawn |
| 48943312 | Width 22.0 mm | Withdrawn |
| 48940055 | Length 55.0 mm | Withdrawn |
| 48940414 | Angle 0.0 ° | Withdrawn |
| 48942114 | Height 14.0 mm | Withdrawn |
| 48942003 | Withdrawn | |
| 48941414 | Length 60.0 mm | Withdrawn |
| 48942016 | Width 22.0 mm | Withdrawn |
| 48942214 | Width 22.0 mm | Withdrawn |
| 48942012 | Angle 0.0 ° | Withdrawn |
| 48943116 | Width 22.0 mm | Withdrawn |
| 48941016 | Angle 8.0 ° | Withdrawn |
| 48942414 | Height 14.0 mm | Withdrawn |
| 48942310 | Height 10.0 mm | Withdrawn |
| 48942314 | Width 22.0 mm | Withdrawn |
| 48943410 | Width 22.0 mm | Withdrawn |
| 48942308 | Angle 0.0 ° | Withdrawn |
| 48943416 | Angle 8.0 ° | Withdrawn |
| 48940412 | Angle 0.0 ° | Withdrawn |
| 48942110 | Length 45.0 mm | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201585 | 2020-08-10 |
| K143163 | 2015-01-26 |
| K142066 | 2014-11-13 |
| K133328 | 2014-05-30 |
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.