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FDA 510(k)

Blue Sky Bio Zygomatic Implant System

K-Number: K190491 · 2019-08-12

ApplicantBlue Sky Bio, LLC
Decision Date2019-08-12
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Blue Sky Bio Zygomatic Implant System is a medical device manufactured by Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2019-08-12 under approval number K190491. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

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. It is manufactured by Blue Sky Bio, LLC. The 510(k) number is K190491.

When was Blue Sky Bio Zygomatic Implant System approved by the FDA?

Blue Sky Bio Zygomatic Implant System received FDA 510(k) clearance on 2019-08-12, under approval number K190491.

What company makes Blue Sky Bio Zygomatic Implant System?

Blue Sky Bio Zygomatic Implant System is manufactured by Blue Sky Bio, LLC.

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.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Blue Sky Bio, LLC

K153064Blue Sky Bio Zygomatic Implant System K180107Blue Sky Bio Aligner K202026Blue Sky Bio CAD-CAM Abutments K201919Blue Sky Bio TAD K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G

View all 8 devices →

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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.

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