Last synced on 23 February 2024 at 11:04 pm

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)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210360
510(k) Type
Traditional
Applicant
Osteonic Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/27/2022
Days to Decision
353 days
Submission Type
Summary

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)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210360
510(k) Type
Traditional
Applicant
Osteonic Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/27/2022
Days to Decision
353 days
Submission Type
Summary