X-Core
X-CORE Mini Inserter, Ø12mm Dismantlable
1manufacturer
31catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Nuvasive, Inc., United States |
|---|---|
| FDA product code | PLR |
| Device type | Spinal Vertebral Body Replacement Device – Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K193506 |
| Record published | 2023-04-13 |
| Record revised | 2025-06-11 (version 9) |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5964967P2 | In distribution | |
| D5961200 | In distribution | |
| 5961200 | In distribution | |
| 5964223P2 | In distribution | |
| 5161604P2 | In distribution | |
| 5961401 | In distribution | |
| 7160035P2 | In distribution | |
| 5964747P2 | In distribution | |
| 7225100 | In distribution | |
| 5964152P2 | In distribution | |
| 5961400 | In distribution | |
| 5964740P2 | In distribution | |
| 5954003 | In distribution | |
| 7160049P2 | In distribution | |
| 7160022P2 | In distribution | |
| 7165100 | In distribution | |
| 7185100 | In distribution | |
| 7161000 | In distribution | |
| 5950003 | In distribution | |
| D5961400 | In distribution | |
| 7221000 | In distribution | |
| 5164000P2 | In distribution | |
| 5164014P2 | In distribution | |
| 5964741P2 | In distribution | |
| 5164004P2 | In distribution | |
| 5962746P2 | In distribution | |
| 5163000P2 | In distribution | |
| 5960010 | In distribution | |
| 5163004P2 | In distribution | |
| 7160063P2 | In distribution | |
| 7181000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alta | Astura Medical | 290 |
| Ascend | Alphatec Spine, Inc. | 267 |
| Matrixx System | Nexxt Spine LLC | 88 |
| Colosseum | Globus Medical, Inc. | 87 |
| Palo Alto Corpectomy Cage System | VB Spine LLC | 56 |
| C-VBR | VB Spine LLC | 53 |
| Trabis® | Coligne AG | 34 |
| CarboClear Cervical VBR System | CarboFix Orthopedics, Ltd. | 31 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 25 |
| Zavation | Zavation | 25 |
| Verteloc Spinal System | Signature Orthopaedics PTY Limited | 17 |
| Fortify | Globus Medical, Inc. | 14 |
Showing 12 of 31. All products under Spinal Vertebral Body Replacement Device – Cervical
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.