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PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214109
510(k) Type
Traditional
Applicant
Kontour(Xi’an) Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/28/2022
Days to Decision
303 days
Submission Type
Summary

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214109
510(k) Type
Traditional
Applicant
Kontour(Xi’an) Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/28/2022
Days to Decision
303 days
Submission Type
Summary