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FDA 510(k)

ROCCIA ALIF, ROCCIA TLIF

K-Number: K180963 · 2018-07-11

ApplicantSilony Medical GmbH
Decision Date2018-07-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROCCIA ALIF, ROCCIA TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2018-07-11 under 510(k) 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. The listed applicant is Silony Medical GmbH. The 510(k) number is K180963.

When did ROCCIA ALIF, ROCCIA TLIF receive FDA 510(k) clearance?

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

Who is the listed applicant for ROCCIA ALIF, ROCCIA TLIF?

The FDA 510(k) record lists Silony Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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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