WaveForm™ L
Lateral Implant, 23mm x 14mm x 45mm, 10 Deg, 3D
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 | 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 | 2021-07-14 |
| Record revised | 2025-10-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WL1-285010 | In distribution | |
| WL1-244510 | In distribution | |
| WL4-266025 | In distribution | |
| WL1-205010 | In distribution | |
| WL4-285015 | In distribution | |
| WL4-246025 | In distribution | |
| WL4-226020 | In distribution | |
| WL4-284525 | In distribution | |
| WL4-284515 | In distribution | |
| WL4-265525 | In distribution | |
| WL1-145015 | In distribution | |
| WL1-125015 | In distribution | |
| WL1-284510 | In distribution | |
| WL4-244525 | In distribution | |
| WL4-264525 | In distribution | |
| WL4-245520 | In distribution | |
| WL4-246020 | In distribution | |
| WL1-105015 | In distribution | |
| WL1-105010 | In distribution | |
| WL1-245510 | In distribution | |
| WL1-245015 | In distribution | |
| WL1-184510 | In distribution | |
| WL4-186015 | In distribution | |
| RP3-209400 | In distribution | |
| WL1-125010 | In distribution | |
| WL1-185010 | In distribution | |
| WL4-265025 | In distribution | |
| WL1-225515 | In distribution | |
| WL1-224515 | In distribution | |
| WL1-144515 | In distribution | |
| WL4-284015 | 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.