Enza-O
ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 17mm
3manufacturers in China registered for this device type
36catalogue 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) | K221324 |
| Record published | 2024-07-16 |
| Record revised | 2025-07-14 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EZO-3038-1511 | In distribution | |
| EZO-102-013 | In distribution | |
| EZO-2632-0813 | In distribution | |
| EZO-3038-1515 | In distribution | |
| EZO-3038-1517 | In distribution | |
| EZO-2632-1517 | In distribution | |
| EZO-3038-0817 | In distribution | |
| EZO-102-009 | In distribution | |
| EZO-102-012 | In distribution | |
| EZO-102-004 | In distribution | |
| EZO-102-018 | In distribution | |
| EZO-102-007 | In distribution | |
| EZO-3038-0813 | In distribution | |
| EZO-102-008 | In distribution | |
| EZO-2632-1515 | In distribution | |
| EZO-3038-0809 | In distribution | |
| EZO-102-001 | In distribution | |
| EZO-102-011 | In distribution | |
| EZO-2632-1511 | In distribution | |
| EZO-102-015 | In distribution | |
| EZO-3038-1513 | In distribution | |
| EZO-2632-1513 | In distribution | |
| EZO-2632-0809 | In distribution | |
| EZO-102-002 | In distribution | |
| EZO-102-003 | In distribution | |
| EZO-2632-0811 | In distribution | |
| EZO-2632-0815 | In distribution | |
| EZO-3038-0811 | In distribution | |
| EZO-102-014 | In distribution | |
| EZO-102-016 | In distribution | |
| EZO-102-017 | In distribution | |
| EZO-102-010 | In distribution | |
| EZO-2632-0817 | In distribution | |
| EZO-3038-0815 | In distribution | |
| EZO-102-005 | In distribution | |
| EZO-102-006 | 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.