FDA 510(k)

PROW FUSION-L

K-Number: K153665 · 2016-09-15

Decision Date2016-09-15

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PROW FUSION-L is a medical device manufactured by Nlt Spine, Ltd.. It received FDA 510(k) clearance on 2016-09-15 under approval number K153665. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROW FUSION-L?

PROW FUSION-L is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by Nlt Spine, Ltd.. The 510(k) number is K153665.

When was PROW FUSION-L approved by the FDA?

PROW FUSION-L received FDA 510(k) clearance on 2016-09-15, under approval number K153665.

What company makes PROW FUSION-L?

PROW FUSION-L is manufactured by Nlt Spine, Ltd..

What is the FDA product code for PROW FUSION-L?

The FDA product code for PROW FUSION-L is MAX.

Other Devices by Nlt Spine, Ltd.

K153786PROW FUSION-V

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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.