FacetBRIDGE® System
K-Number: K161798 · 2016-08-04
ApplicantLdr Spine USA, Inc.
Decision Date2016-08-04
Product CodeMRW
DecisionSubstantially Equivalent
Device Summary
FacetBRIDGE® System is a medical device manufactured by Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2016-08-04 under approval number K161798. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FacetBRIDGE® System?
FacetBRIDGE® System is a medical device that received FDA 510(k) clearance on 2016-08-04. It is manufactured by Ldr Spine USA, Inc.. The 510(k) number is K161798.
When was FacetBRIDGE® System approved by the FDA?
FacetBRIDGE® System received FDA 510(k) clearance on 2016-08-04, under approval number K161798.
What company makes FacetBRIDGE® System?
FacetBRIDGE® System is manufactured by Ldr Spine USA, Inc..
What is the FDA product code for FacetBRIDGE® System?
The FDA product code for FacetBRIDGE® System is MRW.
Other Devices by Ldr Spine USA, Inc.
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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.