Aero-AL
Fixation Anchor, White Cartridge
3manufacturers in China registered for this device type
25catalogue 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 | 2016-09-24 |
| Record revised | 2024-09-11 (version 7) |
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 | Height 11 to 19 mm; angle 4 to 12 °; width 28 to 38 mm; depth 22 to 30 mm; length 22 to 30 mm |
| Distribution end date | 2024-11-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48926615 | Height 15.0 mm | In distribution |
| 48926613 | In distribution | |
| 48926617 | Height 17.0 mm | In distribution |
| 48926619 | Height 19.0 mm | In distribution |
| 48922274 | Angle 4.0 ° | Withdrawn |
| 48923072 | Width 38.0 mm | Withdrawn |
| 48922201 | Length 22.0 mm | Withdrawn |
| 48922238 | Width 28.0 mm | Withdrawn |
| 48922218 | Height 11.0 mm | Withdrawn |
| 48923052 | Height 15.0 mm | Withdrawn |
| 48921011 | Height 11.0 mm | Withdrawn |
| 48922254 | Depth 22.0 mm | Withdrawn |
| 48922618 | Depth 26.0 mm | Withdrawn |
| 48922698 | Width 32.0 mm | Withdrawn |
| 48922258 | Depth 22.0 mm | Withdrawn |
| 48923001 | Length 30.0 mm | Withdrawn |
| 48922234 | Angle 4.0 ° | Withdrawn |
| 48922214 | Depth 22.0 mm | Withdrawn |
| 48921015 | Height 15.0 mm | Withdrawn |
| 48921002 | Withdrawn | |
| 48921013 | Height 13.0 mm | Withdrawn |
| 48923038 | Angle 8.0 ° | Withdrawn |
| 48922638 | Angle 8.0 ° | Withdrawn |
| 48921019 | Height 19.0 mm | Withdrawn |
| 48921017 | Height 17.0 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.