Blue Sky Bio Zygomatic Implant System
K-Number: K190491 · 2019-08-12
Device Summary
Frequently Asked Questions
What is the Blue Sky Bio Zygomatic Implant System?
Blue Sky Bio Zygomatic Implant System is a medical device that received FDA 510(k) clearance on 2019-08-12. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K190491.
When did Blue Sky Bio Zygomatic Implant System receive FDA 510(k) clearance?
Blue Sky Bio Zygomatic Implant System received FDA 510(k) clearance on 2019-08-12, under 510(k) number K190491.
Who is the listed applicant for Blue Sky Bio Zygomatic Implant System?
The FDA 510(k) record lists Blue Sky Bio, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Blue Sky Bio Zygomatic Implant System?
The FDA product code for Blue Sky Bio Zygomatic Implant System is NHA.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Blue Sky Bio, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NHA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.