WaveForm TO
Interbody, 11mm x 28mm x 12mm, 15 Deg, 3D
1manufacturer
83catalogue 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 | Seaspine Orthopedics Corporation, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K213420 |
| Record published | 2025-12-19 |
| Record revised | 2025-10-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WO4-128084 | In distribution | |
| WO1-128144 | In distribution | |
| WO4-928151 | In distribution | |
| WO4-924104 | In distribution | |
| WO4-128125 | In distribution | |
| WO4-928161 | In distribution | |
| WO1-928145 | In distribution | |
| WO4-928091 | In distribution | |
| WO4-132154 | In distribution | |
| WO1-924121 | In distribution | |
| WO1-128114 | In distribution | |
| WO4-924074 | In distribution | |
| WO1-132161 | In distribution | |
| WO1-928161 | In distribution | |
| WO1-928101 | In distribution | |
| WO4-924084 | In distribution | |
| WO4-924135 | In distribution | |
| WO4-132114 | In distribution | |
| WO4-128114 | In distribution | |
| WO4-924125 | In distribution | |
| WO1-928124 | In distribution | |
| WO4-928105 | In distribution | |
| WO4-132155 | In distribution | |
| WO4-132084 | In distribution | |
| WO1-132111 | In distribution | |
| WO4-132161 | In distribution | |
| WO4-128141 | In distribution | |
| WO1-128131 | In distribution | |
| WO4-128151 | In distribution | |
| WO4-928081 | In distribution | |
| WO4-128104 | In distribution | |
| WO1-132121 | In distribution | |
| WO4-128094 | In distribution | |
| WO1-128111 | In distribution | |
| WO4-924154 | In distribution | |
| WO1-928154 | In distribution | |
| WO4-928101 | In distribution | |
| WO4-924094 | In distribution | |
| WO1-928135 | In distribution | |
| WO4-924165 | In distribution | |
| WO1-924111 | In distribution | |
| WO1-924125 | In distribution | |
| WO1-132141 | In distribution | |
| WO1-928074 | In distribution | |
| WO4-132134 | In distribution | |
| WO4-132111 | In distribution | |
| WO4-928134 | In distribution | |
| WO1-128145 | In distribution | |
| WO4-928141 | In distribution | |
| WO1-928164 | In distribution | |
| WO4-128105 | In distribution | |
| WO1-128154 | In distribution | |
| WO4-132121 | In distribution | |
| WO1-924081 | In distribution | |
| WO1-928125 | In distribution | |
| WO1-128141 | In distribution | |
| WO4-128155 | In distribution | |
| WO4-128074 | In distribution | |
| WO1-132151 | In distribution | |
| WO4-924134 | In distribution | |
| WO1-128105 | In distribution | |
| WO4-132141 | In distribution | |
| WO1-128084 | In distribution | |
| WO1-928104 | In distribution | |
| WO1-928131 | In distribution | |
| WO4-132135 | In distribution | |
| WO4-928114 | In distribution | |
| WO1-132091 | In distribution | |
| WO4-924114 | In distribution | |
| WO1-928091 | In distribution | |
| WO1-928081 | In distribution | |
| WO4-924155 | In distribution | |
| WO4-132165 | In distribution | |
| WO1-128134 | In distribution | |
| WO1-928114 | In distribution | |
| WO1-928141 | In distribution | |
| WO1-928121 | In distribution | |
| WO1-924131 | In distribution | |
| WO4-924095 | In distribution | |
| WO1-928105 | In distribution | |
| WO4-132144 | In distribution | |
| WO1-924105 | In distribution | |
| WO4-928135 | 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.