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)
FDA 510(k) clearance K210360 · decided 2022-01-27
Clearance details
- K-number
- K210360
- Device name
- 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)
- Applicant
- Osteonic Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-08
- Decision date
- 2022-01-27
- Days to decision
- 353 days
- Clearance type
- Traditional
- Product code
- GWO
- Device class
- 2
- Regulation number
- 882.5320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| CraniUS Plate (K261058) | CraniUS, LLC | 2026-07-29 |
| TECHFIT Patient-Specific Cranial System (K250297) | Techfit Digital Surgery, Inc. | 2025-10-27 |
| Fusion Craniofacial Implant; Fusion Skull Implant (K250334) | Kelyniam Global, Inc. | 2025-07-25 |
| VSP PEEK Cranial Implant (K231834) | 3D Systems, Inc. | 2024-04-04 |
| MCI-Neuro Fixation System (K212391) | Mci Medical Concept Innovation, Inc. | 2022-10-21 |
| Stryker PEEK Customized Cranial Implant Kit (K203055) | Stryker | 2021-02-09 |
| Optimus NEURO System - Sterile Kit (K190811) | Osteonic Co., Ltd. | 2019-11-27 |
| Stryker PEEK Customized Cranial Implant Kit (K190229) | Stryker | 2019-07-11 |
| Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (K182711) | Kelyniam Global, Inc. | 2019-05-21 |
| Optimus Neuro System (K183352) | Osteonic Co., Ltd. | 2019-01-02 |
| Universal Mesh - Sterile (K182425) | Stryker Leibinger GmbH & Co KG | 2018-11-06 |
| Stryker Universal Mesh (K170725) | Stryker | 2017-11-13 |
Recalls involving this device
No recalls on record reference this clearance.