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FDA 510(k)

Osteo3 ZP Putty

K-Number: K193075 · 2020-06-09

ApplicantSirakoss , Ltd.
Decision Date2020-06-09
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Osteo3 ZP Putty is the device name listed in this FDA 510(k) record. The listed applicant is Sirakoss , Ltd.. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K193075. 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 Osteo3 ZP Putty?

Osteo3 ZP Putty is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Sirakoss , Ltd.. The 510(k) number is K193075.

When did Osteo3 ZP Putty receive FDA 510(k) clearance?

Osteo3 ZP Putty received FDA 510(k) clearance on 2020-06-09, under 510(k) number K193075.

Who is the listed applicant for Osteo3 ZP Putty?

The FDA 510(k) record lists Sirakoss , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteo3 ZP Putty?

The FDA product code for Osteo3 ZP Putty is MQV.

Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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