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FDA 510(k)

FacetBRIDGE System

K-Number: K152137 · 2016-01-25

ApplicantLdr Spine USA
Decision Date2016-01-25
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FacetBRIDGE System is a medical device manufactured by Ldr Spine USA. It received FDA 510(k) clearance on 2016-01-25 under approval number K152137. 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 2016-01-25. It is manufactured by Ldr Spine USA. The 510(k) number is K152137.

When was FacetBRIDGE System approved by the FDA?

FacetBRIDGE System received FDA 510(k) clearance on 2016-01-25, under approval number K152137.

What company makes FacetBRIDGE System?

FacetBRIDGE System is manufactured by Ldr Spine USA.

What is the FDA product code for FacetBRIDGE System?

The FDA product code for FacetBRIDGE System is MRW.

Other Devices by Ldr Spine USA

Related Devices (Code: MRW)

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.