XLX
XLX ACR Handle, Hex Straight Ratcheting
1manufacturer
25catalogue 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 | PHM |
| Device type | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173892 |
| Record published | 2018-07-02 |
| Record revised | 2025-06-11 (version 8) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D1676925 | In distribution | |
| 1845202 | In distribution | |
| 1675088 | In distribution | |
| 1675087 | In distribution | |
| 1676715 | In distribution | |
| 1675089 | In distribution | |
| 1675084 | In distribution | |
| 1676712 | In distribution | |
| 1675073 | In distribution | |
| 1676630 | In distribution | |
| 1676817 | In distribution | |
| 1676635 | In distribution | |
| D1794700 | In distribution | |
| 1676632 | In distribution | |
| 1675078 | In distribution | |
| 1675072 | In distribution | |
| 1676915 | In distribution | |
| 1676703 | In distribution | |
| 1675081 | In distribution | |
| 1676619 | In distribution | |
| 1676917 | In distribution | |
| 1871527 | In distribution | |
| 1676713 | In distribution | |
| 1871535 | In distribution | |
| 1676705 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 2,299 |
| IdentiTi | Alphatec Spine, Inc. | 940 |
| Solar™ Interbody Fusion System | Degen Medical | 805 |
| Transcend Nanotec | Alphatec Spine, Inc. | 466 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 459 |
| E3D-A Interbody System | Evolution Spine, LLC | 308 |
| Battalion | Alphatec Spine, Inc. | 241 |
| Reef L | Seaspine Orthopedics Corporation | 207 |
| IdentiTi II | Alphatec Spine, Inc. | 163 |
| Modulus | Nuvasive, Inc. | 158 |
| Hedron | Globus Medical, Inc. | 156 |
| Roccia | Silony Medical Gmbh | 133 |
Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic
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.