Neo GBR System
K-Number: K160991 · 2017-01-10
ApplicantNeobiotech Co., Ltd.
Decision Date2017-01-10
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Neo GBR System is a medical device manufactured by Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2017-01-10 under approval number K160991. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neo GBR System?
Neo GBR System is a medical device that received FDA 510(k) clearance on 2017-01-10. It is manufactured by Neobiotech Co., Ltd.. The 510(k) number is K160991.
When was Neo GBR System approved by the FDA?
Neo GBR System received FDA 510(k) clearance on 2017-01-10, under approval number K160991.
What company makes Neo GBR System?
Neo GBR System is manufactured by Neobiotech Co., Ltd..
What is the FDA product code for Neo GBR System?
The FDA product code for Neo GBR System is DZL.
Other Devices by Neobiotech Co., Ltd.
Related Devices (Code: DZL)
K151540MC BIO Supertack Tack 3mm, 4mm and 5mmEli-Ka Technologies
K171831Intra-Lock Bone Fixation SystemIntra-Lock International, Inc.
K161857Salvin Tenting Screw SystemSalvin Dental Specialties
K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.
K181854OssBuilder SystemOsstem Implant Co., Ltd.
K201561Membrane Screws and Membrane TacksNeoss Limited
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.