Last synced on 18 April 2025 at 11:05 pm

PolyLock Small Bone Plating System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192323
510(k) Type
Traditional
Applicant
Fusion Orthopedics, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/18/2019
Days to Decision
83 days
Submission Type
Summary

PolyLock Small Bone Plating System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192323
510(k) Type
Traditional
Applicant
Fusion Orthopedics, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/18/2019
Days to Decision
83 days
Submission Type
Summary