Monterey AL
Anterior Lumbar Cage
3manufacturers in China registered for this device type
37catalogue 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 | 2022-04-14 |
| Record revised | 2025-07-14 (version 2) |
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 | Depth 25 to 34 mm; width 33 to 40 mm; angle 10 to 30 °; height 8 to 22 mm; length 20 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 480120165 | Depth 31.0 mm | In distribution |
| 480122402 | Depth 34.0 mm | In distribution |
| 480120532 | Angle 25.0 ° | In distribution |
| 480118535 | Width 33.0 mm | In distribution |
| 480115020 | Length 20.0 mm | In distribution |
| 480118533 | Width 33.0 mm | In distribution |
| 480112105 | Height 12.0 mm | In distribution |
| 480116105 | Depth 31.0 mm | In distribution |
| 480114405 | Width 40.0 mm | In distribution |
| 480108861 | Height 8.0 mm | In distribution |
| 480120100 | Angle 20.0 ° | In distribution |
| 480118400 | Depth 34.0 mm | In distribution |
| 480116532 | Width 33.0 mm | In distribution |
| 480120161 | Height 20.0 mm | In distribution |
| 480110401 | Height 10.0 mm | In distribution |
| 480115025 | Length 25.0 mm | In distribution |
| 480116530 | Height 16.0 mm | In distribution |
| 480108531 | Width 33.0 mm | In distribution |
| 480115030 | Length 30.0 mm | In distribution |
| 480110161 | Height 10.0 mm | In distribution |
| 480116861 | Depth 28.0 mm | In distribution |
| 480115520 | Length 20.0 mm | In distribution |
| 480120865 | Depth 28.0 mm | In distribution |
| 480112161 | Angle 10.0 ° | In distribution |
| 480116160 | Angle 20.0 ° | In distribution |
| 480116100 | Height 16.0 mm | In distribution |
| 480116030 | Length 30.0 mm | In distribution |
| 480118861 | Depth 28.0 mm | In distribution |
| 480112401 | Depth 34.0 mm | In distribution |
| 480122102 | Depth 31.0 mm | In distribution |
| 480114860 | Depth 28.0 mm | In distribution |
| 480120102 | Angle 25.0 ° | In distribution |
| 480120160 | Height 20.0 mm | In distribution |
| 480116400 | Angle 20.0 ° | In distribution |
| 480114865 | Width 36.0 mm | In distribution |
| 480108101 | Height 8.0 mm | In distribution |
| 480120530 | Angle 20.0 ° | In distribution |
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.