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Craniomaxillofacial Distraction System (CMFD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162594
510(k) Type
Traditional
Applicant
SYNTHES USA PRODUCTS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2017
Days to Decision
234 days
Submission Type
Summary

Craniomaxillofacial Distraction System (CMFD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162594
510(k) Type
Traditional
Applicant
SYNTHES USA PRODUCTS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2017
Days to Decision
234 days
Submission Type
Summary