Last synced on 14 November 2025 at 11:06 pm

CALCANEAL TRAUMA SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K061400
510(k) Type
Traditional
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/29/2006
Days to Decision
41 days
Submission Type
Summary

CALCANEAL TRAUMA SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K061400
510(k) Type
Traditional
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/29/2006
Days to Decision
41 days
Submission Type
Summary