Enza™-A Titanium Alif
Bi-Convex 20° Lordotic, 30mm x 38mm, 13mm
3manufacturers in China registered for this device type
38catalogue numbers in this listing
3510(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 | Camber Spine Technologies, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153720 |
| Record published | 2018-07-27 |
| Record revised | 2020-02-05 (version 3) |
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 | Height 9 to 19 mm; width 26 to 38 mm; depth 23 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EZAT-3038-2013 | Height 13 mm | In distribution |
| EZAT-2326-0811 | Depth 23 mm | In distribution |
| EZAT-3038-0813 | Depth 30 mm | In distribution |
| EZAT-2632-0813 | Height 13 mm | In distribution |
| EZAT-2632-2011 | Depth 26 mm | In distribution |
| EZAT-2326-1515 | Depth 23 mm | In distribution |
| EZAT-2326-0815 | Depth 23 mm | In distribution |
| EZA-2632-0901 | In distribution | |
| EZAT-3038-0819 | Height 19 mm | In distribution |
| EZAT-3038-1519 | Depth 30 mm | In distribution |
| EZAT-2632-1517 | Height 17 mm | In distribution |
| EZAT-3038-0817 | Depth 30 mm | In distribution |
| EZAT-2326-1511 | Depth 23 mm | In distribution |
| EZA-2632-0902 | In distribution | |
| EZAT-2632-0809 | Height 9 mm | In distribution |
| EZAT-3038-0809 | Depth 30 mm | In distribution |
| EZAT-3038-1515 | Depth 30 mm | In distribution |
| EZAT-2632-0811 | Depth 26 mm | In distribution |
| EZAT-3038-1517 | Height 15 mm | In distribution |
| EZAT-2632-1511 | Depth 26 mm | In distribution |
| EZAT-2326-1513 | Height 13 mm | In distribution |
| EZAT-2632-2013 | Height 13 mm | In distribution |
| EZAT-2632-2017 | Height 17 mm | In distribution |
| EZAT-3038-0811 | Height 11 mm | In distribution |
| EZAT-2326-1509 | Height 9 mm | In distribution |
| EZAT-3038-2015 | Depth 30 mm | In distribution |
| EZAT-3038-2019 | Depth 30 mm | In distribution |
| EZAT-3038-1511 | Depth 30 mm | In distribution |
| EZAT-2326-0809 | Height 13 mm | In distribution |
| EZAT-3038-2017 | Height 17 mm | In distribution |
| EZAT-2632-1515 | Depth 26 mm | In distribution |
| EZAT-3038-0815 | Height 15 mm | In distribution |
| EZAT-2326-0813 | Height 13 mm | In distribution |
| EZAT-2632-1513 | Height 13 mm | In distribution |
| EZAT-2632-0817 | Height 17 mm | In distribution |
| EZAT-2632-0815 | Depth 26 mm | In distribution |
| EZAT-2632-2015 | Depth 26 mm | In distribution |
| EZAT-3038-1513 | Height 13 mm | 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 |
|---|---|
| K221324 | 2023-03-30 |
| K173432 | 2018-04-18 |
| K153720 | 2016-05-03 |
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.