Last synced on 18 April 2025 at 11:05 pm

Blue Sky Bio Zygomatic Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153064
510(k) Type
Traditional
Applicant
BLUE SKY BIO, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/29/2016
Days to Decision
190 days
Submission Type
Summary

Blue Sky Bio Zygomatic Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153064
510(k) Type
Traditional
Applicant
BLUE SKY BIO, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/29/2016
Days to Decision
190 days
Submission Type
Summary