WaveForm TA
Interbody, 11mm x 36mm x 12mm, 20 Deg, 3D
1manufacturer
14catalogue 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) | K201755 |
| Record published | 2021-02-06 |
| 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 |
|---|---|---|
| WT1-932148 | In distribution | |
| WT1-928088 | In distribution | |
| WT1-136158 | In distribution | |
| WT1-932105 | In distribution | |
| WT1-928158 | In distribution | |
| WT1-928128 | In distribution | |
| WT1-932158 | In distribution | |
| WT1-928098 | In distribution | |
| WT1-932145 | In distribution | |
| WT4-136122 | In distribution | |
| WT1-932155 | In distribution | |
| WT1-932115 | In distribution | |
| WT1-932108 | In distribution | |
| WT4-136102 | 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.