Last synced on 2 May 2025 at 11:05 pm

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243889
510(k) Type
Traditional
Applicant
Orthocell Ltd.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
4/2/2025
Days to Decision
105 days
Submission Type
Summary

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243889
510(k) Type
Traditional
Applicant
Orthocell Ltd.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
4/2/2025
Days to Decision
105 days
Submission Type
Summary