Neurology · 7 clearances · 7 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Osteonic Co., Ltd. | 1 | 0 | 2022-01-27 |
| Stryker | 1 | 0 | 2021-02-09 |
| 3D Systems, Inc. | 1 | 0 | 2024-04-04 |
| Kelyniam Global, Inc. | 1 | 0 | 2025-07-25 |
| CraniUS, LLC | 1 | 1 | 2026-07-29 |
| Mci Medical Concept Innovation, Inc. | 1 | 0 | 2022-10-21 |
| Techfit Digital Surgery, Inc. | 1 | 1 | 2025-10-27 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 20670 | CPT | — | Medium | Cranioplasty with bone graft; CPT codes 20670-20680 cover bone grafting procedures including cranial reconstruction |
| 62000 | CPT | — | Medium | Elevation of depressed skull fracture; may apply to cranioplasty reconstruction scenarios |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-07-29 | K261058 | CraniUS, LLC | CraniUS Plate |
| 2025-10-27 | K250297 | Techfit Digital Surgery, Inc. | TECHFIT Patient-Specific Cranial System |
| 2025-07-25 | K250334 | Kelyniam Global, Inc. | Fusion Craniofacial Implant; Fusion Skull Implant |
| 2024-04-04 | K231834 | 3D Systems, Inc. | VSP PEEK Cranial Implant |
| 2022-10-21 | K212391 | Mci Medical Concept Innovation, Inc. | MCI-Neuro Fixation System |
| 2022-01-27 | K210360 | Osteonic Co., Ltd. | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) |
| 2021-02-09 | K203055 | Stryker | Stryker PEEK Customized Cranial Implant Kit |