FDA 510(k)

Premia Spine XL Instruments

K-Number: K191854 · 2019-10-08

Decision Date2019-10-08

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Premia Spine XL Instruments is a medical device manufactured by Premia Spine, Ltd.. It received FDA 510(k) clearance on 2019-10-08 under approval number K191854. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Premia Spine XL Instruments?

Premia Spine XL Instruments is a medical device that received FDA 510(k) clearance on 2019-10-08. It is manufactured by Premia Spine, Ltd.. The 510(k) number is K191854.

When was Premia Spine XL Instruments approved by the FDA?

Premia Spine XL Instruments received FDA 510(k) clearance on 2019-10-08, under approval number K191854.

What company makes Premia Spine XL Instruments?

Premia Spine XL Instruments is manufactured by Premia Spine, Ltd..

What is the FDA product code for Premia Spine XL Instruments?

The FDA product code for Premia Spine XL Instruments is OLO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.