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BIOCERAMIC ORBITAL IMPLANT, ORBTEX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110554
510(k) Type
Traditional
Applicant
CERAMISYS LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2011
Days to Decision
247 days
Submission Type
Statement

BIOCERAMIC ORBITAL IMPLANT, ORBTEX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110554
510(k) Type
Traditional
Applicant
CERAMISYS LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2011
Days to Decision
247 days
Submission Type
Statement