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FDA 510(k)

FAVO S-TLIF

K-Number: K190680 · 2019-07-18

ApplicantSilony Medical GmbH
Decision Date2019-07-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FAVO S-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 2019-07-18 under 510(k) number K190680. 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 FAVO S-TLIF?

FAVO S-TLIF is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Silony Medical GmbH. The 510(k) number is K190680.

When did FAVO S-TLIF receive FDA 510(k) clearance?

FAVO S-TLIF received FDA 510(k) clearance on 2019-07-18, under 510(k) number K190680.

Who is the listed applicant for FAVO S-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 FAVO S-TLIF?

The FDA product code for FAVO S-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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