Zavation Lateral CL5 PEEK NanoPrime Cage
Lateral CL5 PEEK NanoPrime Cage - 18mm x 50mm x 10mm, 12°
3manufacturers in China registered for this device type
87catalogue numbers in this listing
1510(k) clearance
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 | Zavation, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K231743 |
| Record published | 2025-07-08 |
| Record revised | 2025-11-20 (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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NLL2250-0010 | In distribution | |
| NLL1850-1210 | In distribution | |
| NLL2255-1214 | In distribution | |
| NLL1850-0812 | In distribution | |
| NLL1850-0808 | In distribution | |
| NLL2255-0814 | In distribution | |
| NLL2245-0814 | In distribution | |
| NLL1855-0814 | In distribution | |
| NLL2250-1210 | In distribution | |
| NLL1855-0808 | In distribution | |
| NLL1845-0008 | In distribution | |
| NLL1855-0010 | In distribution | |
| NLL1855-0008 | In distribution | |
| NLL1845-0812 | In distribution | |
| NLL2245-0812 | In distribution | |
| NLL2245-0808 | In distribution | |
| NLL1860-0808 | In distribution | |
| NLL1850-0008 | In distribution | |
| NLL2255-0014 | In distribution | |
| NLL2245-0014 | In distribution | |
| NLL2250-0012 | In distribution | |
| NLL2260-0814 | In distribution | |
| NLL2250-0808 | In distribution | |
| NLL2260-0808 | In distribution | |
| NLL1850-0810 | In distribution | |
| NLL2255-0012 | In distribution | |
| NLL1860-0812 | In distribution | |
| NLL2260-0014 | In distribution | |
| NLL1850-0014 | In distribution | |
| NLL1860-1212 | In distribution | |
| NLL2260-1212 | In distribution | |
| NLL2245-0010 | In distribution | |
| NLL2260-1214 | In distribution | |
| NLL1845-0014 | In distribution | |
| NLL2245-1212 | In distribution | |
| NLL1845-0810 | In distribution | |
| NLL2255-0810 | In distribution | |
| NLL1845-1214 | In distribution | |
| NLL1855-1214 | In distribution | |
| NLL1845-0808 | In distribution | |
| NLL1845-1210 | In distribution | |
| NLL2255-0008 | In distribution | |
| NLL1855-0812 | In distribution | |
| NLL1855-1212 | In distribution | |
| NLL1855-0810 | In distribution | |
| NLL1860-0014 | In distribution | |
| NLL1860-0008 | In distribution | |
| NLL2260-0008 | In distribution | |
| NLL1845-0010 | In distribution | |
| NLL1860-0012 | In distribution | |
| NLL2255-0812 | In distribution | |
| NLL1855-0014 | In distribution | |
| NLL1845-0814 | In distribution | |
| NLL1850-1212 | In distribution | |
| NLL1860-1210 | In distribution | |
| NLL1860-0010 | In distribution | |
| NLL2260-0810 | In distribution | |
| NLL1855-1210 | In distribution | |
| NLL2250-0810 | In distribution | |
| NLL2255-1210 | In distribution | |
| NLL1860-0814 | In distribution | |
| NLL2250-0014 | In distribution | |
| NLL2260-0012 | In distribution | |
| NLL2245-0810 | In distribution | |
| NLL2245-1210 | In distribution | |
| NLL2260-1210 | In distribution | |
| NLL1850-0012 | In distribution | |
| NLL1860-1214 | In distribution | |
| NLL2250-0008 | In distribution | |
| NLL2255-0808 | In distribution | |
| NLL1850-0814 | In distribution | |
| NLL1850-1214 | In distribution | |
| NLL2260-0812 | In distribution | |
| NLL2245-0008 | In distribution | |
| NLL2255-1212 | In distribution | |
| NLL2250-0812 | In distribution | |
| NLL2260-0010 | In distribution | |
| NLL2245-0012 | In distribution | |
| NLL2245-1214 | In distribution | |
| NLL2250-1212 | In distribution | |
| NLL2255-0010 | In distribution | |
| NLL2250-0814 | In distribution | |
| NLL1845-0012 | In distribution | |
| NLL2250-1214 | In distribution | |
| NLL1845-1212 | In distribution | |
| NLL1860-0810 | In distribution | |
| NLL1850-0010 | 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 |
|---|---|
| K142271 | 2014-12-19 |
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.