Enza
Intervertebral Locking Plate , 32mm x 38mm
3manufacturers in China registered for this device type
37catalogue 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 | 2016-09-20 |
| Record revised | 2020-02-24 (version 5) |
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 | Depth 0 to 38 mm; width 0 to 38 mm; height 0 to 21 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB-001-015 | Depth 32 mm | In distribution |
| CB-001-033 | Width 32 mm | In distribution |
| CB-001-026 | Lordosis 15 Degree | In distribution |
| CB-001-011 | Depth 32 mm | In distribution |
| CB-001-035 | Depth 38 mm | In distribution |
| CB-001-030 | Depth 32 mm | In distribution |
| CB-001-028 | Depth 32 mm | In distribution |
| CB-001-007 | Depth 32 mm | In distribution |
| CB-001-020 | Lordosis 15 Degree | In distribution |
| CB-001-004 | Lordosis 8 Degree | In distribution |
| CB-001-022 | Lordosis 15 Degree | In distribution |
| CC-002-36 | Depth 0 mm | In distribution |
| CB-001-008 | Lordosis 8 Degree | In distribution |
| CB-001-039 | 0 | In distribution |
| CB-001-027 | Width 26 mm | In distribution |
| CB-001-010 | Lordosis 8 Degree | In distribution |
| CC-002-38 | Depth 0 mm | In distribution |
| CB-001-034 | Lordosis 15 Degree | In distribution |
| CB-001-031 | Width 32 mm | In distribution |
| CB-001-018 | Lordosis 8 Degree | In distribution |
| CB-001-037 | 0 | In distribution |
| CB-001-025 | Depth 32 mm | In distribution |
| CB-001-012 | Depth 32 mm | In distribution |
| CB-001-016 | Lordosis 8 Degree | In distribution |
| CB-001-032 | Depth 38 mm | In distribution |
| CB-001-002 | Lordosis 8 Degree | In distribution |
| CB-001-009 | Depth 32 mm | In distribution |
| CB-001-017 | Depth 32 mm | In distribution |
| CB-001-001 | Depth 23 mm | In distribution |
| CB-001-019 | Depth 28 mm | In distribution |
| CC-002-37 | 0 | In distribution |
| CB-001-038 | Depth 32 mm | In distribution |
| CB-001-013 | Depth 32 mm | In distribution |
| CB-001-021 | Depth 28 mm | In distribution |
| CB-001-003 | Depth 23 mm | In distribution |
| CB-001-014 | Lordosis 8 Degree | In distribution |
| CB-001-029 | Width 26 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.