Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Blue Sky Bio Zygomatic Implant System

K-Number: K153064 · 2016-04-29

ApplicantBlue Sky Bio, LLC
Decision Date2016-04-29
Product CodeDZE
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 2016-04-29 under approval number K153064. The device is classified under product code DZE. 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 2016-04-29. It is manufactured by Blue Sky Bio, LLC. The 510(k) number is K153064.

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

Blue Sky Bio Zygomatic Implant System received FDA 510(k) clearance on 2016-04-29, under approval number K153064.

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 DZE.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

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

K180107Blue Sky Bio Aligner K190491Blue Sky Bio Zygomatic Implant System 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 →

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

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.

↑