Foundation Surgical Interwedge
Interwedge is a lateral lumbar interbody fusion implant for skeletally mature patients with degenerative disc disease at one or two adjacent levels from L1 to S1. Patients should have…
Interwedge is a lateral lumbar interbody fusion implant for skeletally mature patients with degenerative disc disease at one or two adjacent levels from L1 to S1. Patients should have completed at least six months of nonoperative treatment and may have up to grade 1 spondylolisthesis or retrolisthesis.
The titanium alloy construct combines an intervertebral spacer, lateral plate and contralateral staple to stabilize the treated segment. The plate and staple form an integrated fixation arrangement, with bone screws securing the implant.
Listed Item
Interwedge, 22W x 60L x 12H x 15L°, Sterile (x1)
Graft and Fixation
The implant must be filled with autogenous bone graft or allogeneic cancellous, cortical or corticocancellous bone. Use the two accompanying titanium alloy screws; additional supplemental fixation is required if fewer than two screws are used.
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Foundation Surgical Group, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K241487 |
| Record published | 2026-02-18 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LB22601215 | In distribution | |
| FS20-55600 | In distribution | |
| FS20-55550 | In distribution | |
| LB22551210 | In distribution | |
| FS20-55450 | In distribution | |
| LB22450803 | In distribution | |
| LB22401410 | In distribution | |
| LB2H | In distribution | |
| FS20-65350 | In distribution | |
| LB22601410 | In distribution | |
| LB22400803 | In distribution | |
| LB22451215 | In distribution | |
| LB22401415 | In distribution | |
| LB22500803 | In distribution | |
| LB22451410 | In distribution | |
| LB22401215 | In distribution | |
| LB22501010 | In distribution | |
| LB22551215 | In distribution | |
| LB22501210 | In distribution | |
| LB22601010 | In distribution | |
| LB22451010 | In distribution | |
| LB22501410 | In distribution | |
| FS20-65250 | In distribution | |
| FS20-65400 | In distribution | |
| LB22601420 | In distribution | |
| LB22451420 | In distribution | |
| LB22451415 | In distribution | |
| LB22551010 | In distribution | |
| FS20-55350 | In distribution | |
| LB22551415 | In distribution | |
| FS20-65500 | In distribution | |
| LB22550803 | In distribution | |
| LB22601415 | In distribution | |
| FS20-65600 | In distribution | |
| LB22401010 | In distribution | |
| FS20-65300 | In distribution | |
| LB22600803 | In distribution | |
| FS20-65550 | In distribution | |
| FS20-65450 | In distribution | |
| FS20-55250 | In distribution | |
| LB22501420 | In distribution | |
| LB22401210 | In distribution | |
| FS20-55300 | In distribution | |
| LB22451210 | In distribution | |
| FS20-55400 | In distribution | |
| LB22401420 | In distribution | |
| LB22551420 | In distribution | |
| LB22601210 | In distribution | |
| LB22501415 | In distribution | |
| LB22551410 | In distribution | |
| FS20-55500 | In distribution | |
| LB22501215 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261809 | 2026-07-31 |
| K241487 | 2024-10-02 |
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.