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OsteoFab Patient Specific Cranial Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180064
510(k) Type
Traditional
Applicant
Oxford Performance Materials, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/2018
Days to Decision
199 days
Submission Type
Summary

OsteoFab Patient Specific Cranial Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180064
510(k) Type
Traditional
Applicant
Oxford Performance Materials, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/2018
Days to Decision
199 days
Submission Type
Summary