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FDA 510(k)

SAHARA Stabilization System

K-Number: K190179 · 2019-10-03

ApplicantK2m, Inc.
Decision Date2019-10-03
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAHARA Stabilization System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2019-10-03 under approval number K190179. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAHARA Stabilization System?

SAHARA Stabilization System is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by K2m, Inc.. The 510(k) number is K190179.

When was SAHARA Stabilization System approved by the FDA?

SAHARA Stabilization System received FDA 510(k) clearance on 2019-10-03, under approval number K190179.

What company makes SAHARA Stabilization System?

SAHARA Stabilization System is manufactured by K2m, Inc..

What is the FDA product code for SAHARA Stabilization System?

The FDA product code for SAHARA Stabilization System is OVD.

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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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