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ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142161
510(k) Type
Traditional
Applicant
CONFORMIS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2014
Days to Decision
100 days
Submission Type
Summary

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142161
510(k) Type
Traditional
Applicant
CONFORMIS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2014
Days to Decision
100 days
Submission Type
Summary