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FDA 510(k)

Orthoss(R)

K-Number: K190754 · 2019-06-23

ApplicantGeistlich Pharma AG
Decision Date2019-06-23
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Orthoss(R) is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2019-06-23 under 510(k) number K190754. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orthoss(R)?

Orthoss(R) is a medical device that received FDA 510(k) clearance on 2019-06-23. The listed applicant is Geistlich Pharma AG. The 510(k) number is K190754.

When did Orthoss(R) receive FDA 510(k) clearance?

Orthoss(R) received FDA 510(k) clearance on 2019-06-23, under 510(k) number K190754.

Who is the listed applicant for Orthoss(R)?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthoss(R)?

The FDA product code for Orthoss(R) is MQV.

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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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