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MAXLOCK EXTREME ELBOW FRACTURE SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K141301
510(k) Type
Traditional
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/11/2014
Days to Decision
53 days
Submission Type
Summary

MAXLOCK EXTREME ELBOW FRACTURE SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K141301
510(k) Type
Traditional
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/11/2014
Days to Decision
53 days
Submission Type
Summary