FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
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)
K Number: K210360
·
Decision Jan 27, 2022
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
20
Review Days
353
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- 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)
- K Number
- K210360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteonic Co., Ltd.
- Date Received
- February 8, 2021
- Decision Date
- January 27, 2022
- Product Code
- GWO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWO), ordered by most recent decision date.
TECHFIT Patient-Specific Cranial System
FDA 510(k)
FDA Class 2
·Neurology
Fusion Craniofacial Implant; Fusion Skull Implant
FDA 510(k)
FDA Class 2
·Neurology
VSP PEEK Cranial Implant
FDA 510(k)
FDA Class 2
·Neurology
MCI-Neuro Fixation System
FDA 510(k)
FDA Class 2
·Neurology
Stryker PEEK Customized Cranial Implant Kit
FDA 510(k)
FDA Class 2
·Neurology
Optimus NEURO System - Sterile Kit
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Osteonic Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K254182 | Aster | Feb 26, 2026 | Substantially Equivalent |
| K243469 | SIGNEX | May 29, 2025 | Substantially Equivalent |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Dec 3, 2024 | Substantially Equivalent |
| K243470 | Fix2Lock (PEEK Self Punching) | Dec 3, 2024 | Substantially Equivalent |
| K230546 | SIGNEX | Jun 11, 2024 | Substantially Equivalent |
| K233659 | Suture Wing | Dec 26, 2023 | Substantially Equivalent |
| K231322 | Fix2Lock(PEEK Self Punching) | Jun 7, 2023 | Substantially Equivalent |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | May 31, 2023 | Substantially Equivalent |
| K211992 | Ortho MI System | Oct 15, 2021 | Substantially Equivalent |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | Aug 27, 2021 | Substantially Equivalent |