Zavation NanoPrime Labyrinth Plif
NanoPrime LABYRINTH PLIF 10mmx32mmx12deg -10mm
3manufacturers in China registered for this device type
109catalogue 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 | 2025-06-06 |
| 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 |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 954-102312-09 | In distribution | |
| 954-102307-12 | In distribution | |
| 954-103212-10 | In distribution | |
| 954-102700-11 | In distribution | |
| 954-102305-10 | In distribution | |
| 954-103205-09 | In distribution | |
| 954-102305-16 | In distribution | |
| 954-102705-13 | In distribution | |
| 954-102700-12 | In distribution | |
| 954-103205-15 | In distribution | |
| 954-103207-14 | In distribution | |
| 954-102312-16 | In distribution | |
| 954-102300-07 | In distribution | |
| 954-102307-11 | In distribution | |
| 954-102705-14 | In distribution | |
| 954-103200-15 | In distribution | |
| 954-103200-08 | In distribution | |
| 954-102307-16 | In distribution | |
| 954-103212-11 | In distribution | |
| 954-102305-14 | In distribution | |
| 954-102305-13 | In distribution | |
| 954-102312-10 | In distribution | |
| 954-103205-10 | In distribution | |
| 954-103212-15 | In distribution | |
| 954-102700-10 | In distribution | |
| 954-103212-16 | In distribution | |
| 954-103207-11 | In distribution | |
| 954-102705-15 | In distribution | |
| 954-102307-09 | In distribution | |
| 954-102712-12 | In distribution | |
| 954-103200-11 | In distribution | |
| 954-102705-12 | In distribution | |
| 954-103200-12 | In distribution | |
| 954-102707-09 | In distribution | |
| 954-102312-08 | In distribution | |
| 954-102705-09 | In distribution | |
| 954-103205-08 | In distribution | |
| 954-103205-13 | In distribution | |
| 954-102712-14 | In distribution | |
| 954-103200-16 | In distribution | |
| 954-102312-13 | In distribution | |
| 954-102712-16 | In distribution | |
| 954-102312-14 | In distribution | |
| 954-103212-14 | In distribution | |
| 954-102705-08 | In distribution | |
| 954-102705-11 | In distribution | |
| 954-103207-12 | In distribution | |
| 954-102700-13 | In distribution | |
| 954-102707-14 | In distribution | |
| 954-102300-09 | In distribution | |
| 954-102707-10 | In distribution | |
| 954-103207-13 | In distribution | |
| 954-103207-15 | In distribution | |
| 954-102712-11 | In distribution | |
| 954-102712-10 | In distribution | |
| 954-103200-14 | In distribution | |
| 954-102700-15 | In distribution | |
| 954-102300-10 | In distribution | |
| 954-103207-09 | In distribution | |
| 954-102707-11 | In distribution | |
| 954-102300-16 | In distribution | |
| 954-103207-10 | In distribution | |
| 954-102700-14 | In distribution | |
| 954-103200-09 | In distribution | |
| 954-102307-14 | In distribution | |
| 954-102305-11 | In distribution | |
| 954-103212-13 | In distribution | |
| 954-102312-11 | In distribution | |
| 954-102312-12 | In distribution | |
| 954-102707-08 | In distribution | |
| 954-102712-15 | In distribution | |
| 954-103205-12 | In distribution | |
| 954-102707-13 | In distribution | |
| 954-102305-09 | In distribution | |
| 954-102307-08 | In distribution | |
| 954-102707-16 | In distribution | |
| 954-102707-15 | In distribution | |
| 954-102700-08 | In distribution | |
| 954-102307-13 | In distribution | |
| 954-103207-16 | In distribution | |
| 954-102705-10 | In distribution | |
| 954-102712-13 | In distribution | |
| 954-102305-12 | In distribution | |
| 954-103205-11 | In distribution | |
| 954-102300-13 | In distribution | |
| 954-102300-12 | In distribution | |
| 954-102712-08 | In distribution | |
| 954-103205-16 | In distribution | |
| 954-102307-15 | In distribution | |
| 954-102700-16 | In distribution | |
| 954-102700-09 | In distribution | |
| 954-103200-07 | In distribution | |
| 954-102307-10 | In distribution | |
| 954-102705-16 | In distribution | |
| 954-103200-13 | In distribution | |
| 954-102305-15 | In distribution | |
| 954-102300-11 | In distribution | |
| 954-103212-12 | In distribution | |
| 954-102700-07 | In distribution | |
| 954-103205-14 | In distribution | |
| 954-102712-09 | In distribution | |
| 954-102312-15 | In distribution | |
| 954-102300-15 | In distribution | |
| 954-103200-10 | In distribution | |
| 954-102707-12 | In distribution | |
| 954-102300-14 | In distribution | |
| 954-103207-08 | In distribution | |
| 954-102300-08 | In distribution | |
| 954-102305-08 | 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.