Zavation NanoPrime Labyrinth CIF
NanoPrime LABYRINTH CIF 13mmx15mm , 10deg , 12mm
3manufacturers in China registered for this device type
216catalogue 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) | K233509 |
| Record published | 2024-09-23 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 953-0812 | In distribution | |
| 950-0012 | In distribution | |
| 951-1012 | In distribution | |
| 952-0609 | In distribution | |
| 953-0709 | In distribution | |
| 950-0709 | In distribution | |
| 951-0607 | In distribution | |
| 952-0508 | In distribution | |
| 952-0607 | In distribution | |
| 953-0605 | In distribution | |
| 951-0912 | In distribution | |
| 950-0810 | In distribution | |
| 950-0610 | In distribution | |
| 952-0811 | In distribution | |
| 953-0505 | In distribution | |
| 952-0505 | In distribution | |
| 952-0712 | In distribution | |
| 953-0611 | In distribution | |
| 952-0005 | In distribution | |
| 952-0510 | In distribution | |
| 950-0007 | In distribution | |
| 952-1007 | In distribution | |
| 952-0808 | In distribution | |
| 950-1010 | In distribution | |
| 950-0010 | In distribution | |
| 952-0709 | In distribution | |
| 950-0009 | In distribution | |
| 952-1012 | In distribution | |
| 950-0005 | In distribution | |
| 950-0611 | In distribution | |
| 950-1005 | In distribution | |
| 953-0705 | In distribution | |
| 950-0508 | In distribution | |
| 952-0910 | In distribution | |
| 953-0506 | In distribution | |
| 951-1010 | In distribution | |
| 953-0512 | In distribution | |
| 952-0009 | In distribution | |
| 951-0808 | In distribution | |
| 950-0509 | In distribution | |
| 951-0812 | In distribution | |
| 950-0607 | In distribution | |
| 951-0910 | In distribution | |
| 951-0807 | In distribution | |
| 950-0609 | In distribution | |
| 952-0807 | In distribution | |
| 951-0805 | In distribution | |
| 951-0606 | In distribution | |
| 950-0008 | In distribution | |
| 952-0806 | In distribution | |
| 952-1006 | In distribution | |
| 951-0707 | In distribution | |
| 953-0809 | In distribution | |
| 951-0706 | In distribution | |
| 953-0905 | In distribution | |
| 951-0612 | In distribution | |
| 951-0507 | In distribution | |
| 951-0508 | In distribution | |
| 953-0811 | In distribution | |
| 952-1008 | In distribution | |
| 950-0806 | In distribution | |
| 950-0708 | In distribution | |
| 950-1007 | In distribution | |
| 952-0612 | In distribution | |
| 953-0807 | In distribution | |
| 953-1012 | In distribution | |
| 953-0706 | In distribution | |
| 952-0705 | In distribution | |
| 950-0811 | In distribution | |
| 950-0910 | In distribution | |
| 952-0708 | In distribution | |
| 953-0010 | In distribution | |
| 952-0906 | In distribution | |
| 951-0806 | In distribution | |
| 953-0707 | In distribution | |
| 953-0009 | In distribution | |
| 953-0708 | In distribution | |
| 951-1007 | In distribution | |
| 950-0506 | In distribution | |
| 952-0605 | In distribution | |
| 951-0510 | In distribution | |
| 951-0007 | In distribution | |
| 951-0011 | In distribution | |
| 952-0809 | In distribution | |
| 953-0007 | In distribution | |
| 950-0905 | In distribution | |
| 953-0906 | In distribution | |
| 950-0911 | In distribution | |
| 952-0812 | In distribution | |
| 951-0511 | In distribution | |
| 951-0605 | In distribution | |
| 950-1009 | In distribution | |
| 952-0608 | In distribution | |
| 952-0905 | In distribution | |
| 953-0012 | In distribution | |
| 951-0809 | In distribution | |
| 952-0810 | In distribution | |
| 950-0605 | In distribution | |
| 953-0805 | In distribution | |
| 950-0608 | In distribution | |
| 950-0807 | In distribution | |
| 951-0008 | In distribution | |
| 953-0507 | In distribution | |
| 951-0012 | In distribution | |
| 950-0511 | In distribution | |
| 953-0711 | In distribution | |
| 952-0610 | In distribution | |
| 953-0609 | In distribution | |
| 951-0710 | In distribution | |
| 953-0810 | In distribution | |
| 950-0808 | In distribution | |
| 950-0011 | In distribution | |
| 951-0609 | In distribution | |
| 951-0908 | In distribution | |
| 953-0005 | In distribution | |
| 950-0612 | In distribution | |
| 952-0706 | In distribution | |
| 951-1008 | In distribution | |
| 953-0710 | In distribution | |
| 953-0610 | In distribution | |
| 953-0808 | In distribution | |
| 950-0812 | In distribution | |
| 950-0912 | In distribution | |
| 951-1011 | In distribution | |
| 952-1011 | In distribution | |
| 951-0907 | In distribution | |
| 952-0012 | In distribution | |
| 952-0006 | In distribution | |
| 952-0507 | In distribution | |
| 953-0011 | In distribution | |
| 952-0710 | In distribution | |
| 952-0606 | In distribution | |
| 950-0908 | In distribution | |
| 952-0011 | In distribution | |
| 950-0606 | In distribution | |
| 951-0810 | In distribution | |
| 951-0811 | In distribution | |
| 952-0509 | In distribution | |
| 951-0006 | In distribution | |
| 951-0705 | In distribution | |
| 951-0712 | In distribution | |
| 953-0909 | In distribution | |
| 950-1012 | In distribution | |
| 953-0510 | In distribution | |
| 950-0706 | In distribution | |
| 950-0907 | In distribution | |
| 950-0805 | In distribution | |
| 952-0911 | In distribution | |
| 952-0007 | In distribution | |
| 951-1006 | In distribution | |
| 951-0909 | In distribution | |
| 953-0908 | In distribution | |
| 953-0907 | In distribution | |
| 952-0711 | In distribution | |
| 951-0911 | In distribution | |
| 951-0010 | In distribution | |
| 952-0907 | In distribution | |
| 951-0711 | In distribution | |
| 952-0908 | In distribution | |
| 952-1010 | In distribution | |
| 952-0512 | In distribution | |
| 951-0611 | In distribution | |
| 952-1009 | In distribution | |
| 950-1006 | In distribution | |
| 952-0010 | In distribution | |
| 953-0607 | In distribution | |
| 951-0512 | In distribution | |
| 950-0906 | In distribution | |
| 952-0511 | In distribution | |
| 953-0508 | In distribution | |
| 950-1008 | In distribution | |
| 950-0710 | In distribution | |
| 951-0906 | In distribution | |
| 950-0512 | In distribution | |
| 952-0805 | In distribution | |
| 951-0505 | In distribution | |
| 952-0707 | In distribution | |
| 950-0510 | In distribution | |
| 950-0006 | In distribution | |
| 950-0909 | In distribution | |
| 951-0009 | In distribution | |
| 953-0911 | In distribution | |
| 951-0608 | In distribution | |
| 952-1005 | In distribution | |
| 953-0008 | In distribution | |
| 952-0912 | In distribution | |
| 953-0606 | In distribution | |
| 951-0708 | In distribution | |
| 950-0705 | In distribution | |
| 952-0008 | In distribution | |
| 953-0612 | In distribution | |
| 952-0611 | In distribution | |
| 951-1005 | In distribution | |
| 951-0506 | In distribution | |
| 951-0709 | In distribution | |
| 951-1009 | In distribution | |
| 950-0505 | In distribution | |
| 950-0707 | In distribution | |
| 951-0610 | In distribution | |
| 950-0507 | In distribution | |
| 950-0712 | In distribution | |
| 951-0509 | In distribution | |
| 953-0608 | In distribution | |
| 953-0712 | In distribution | |
| 953-0910 | In distribution | |
| 953-0006 | In distribution | |
| 951-0005 | In distribution | |
| 950-0711 | In distribution | |
| 951-0905 | In distribution | |
| 952-0909 | In distribution | |
| 953-0509 | In distribution | |
| 953-0806 | In distribution | |
| 950-1011 | In distribution | |
| 953-0511 | In distribution | |
| 952-0506 | In distribution | |
| 950-0809 | 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.