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Fix2Lock (PEEK Self Punching)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243470
510(k) Type
Special
Applicant
Osteonic Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/3/2024
Days to Decision
25 days
Submission Type
Summary

Fix2Lock (PEEK Self Punching)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243470
510(k) Type
Special
Applicant
Osteonic Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/3/2024
Days to Decision
25 days
Submission Type
Summary