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FDA 510(k)

ROCCIA ALIF, ROCCIA TLIF

K-Number: K180963 · 2018-07-11

Decision Date2018-07-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROCCIA ALIF, ROCCIA TLIF is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2018-07-11 under approval number K180963. 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 ROCCIA ALIF, ROCCIA TLIF?

ROCCIA ALIF, ROCCIA TLIF is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by Silony Medical GmbH. The 510(k) number is K180963.

When was ROCCIA ALIF, ROCCIA TLIF approved by the FDA?

ROCCIA ALIF, ROCCIA TLIF received FDA 510(k) clearance on 2018-07-11, under approval number K180963.

What company makes ROCCIA ALIF, ROCCIA TLIF?

ROCCIA ALIF, ROCCIA TLIF is manufactured by Silony Medical GmbH.

What is the FDA product code for ROCCIA ALIF, ROCCIA TLIF?

The FDA product code for ROCCIA ALIF, ROCCIA TLIF is MAX.

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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.