Last synced on 23 September 2022 at 11:05 pm

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190523
510(k) Type
Traditional
Applicant
OssDsign AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
10/10/2019
Days to Decision
220 days
Submission Type
Summary

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190523
510(k) Type
Traditional
Applicant
OssDsign AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
10/10/2019
Days to Decision
220 days
Submission Type
Summary