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FDA 510(k)

Cartiva SCI instrumentation set

K-Number: K192156 · 2019-09-04

ApplicantCartiva, Inc.
Decision Date2019-09-04
Product CodeQBO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cartiva SCI instrumentation set is a medical device manufactured by Cartiva, Inc.. It received FDA 510(k) clearance on 2019-09-04 under approval number K192156. The device is classified under product code QBO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cartiva SCI instrumentation set?

Cartiva SCI instrumentation set is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Cartiva, Inc.. The 510(k) number is K192156.

When was Cartiva SCI instrumentation set approved by the FDA?

Cartiva SCI instrumentation set received FDA 510(k) clearance on 2019-09-04, under approval number K192156.

What company makes Cartiva SCI instrumentation set?

Cartiva SCI instrumentation set is manufactured by Cartiva, Inc..

What is the FDA product code for Cartiva SCI instrumentation set?

The FDA product code for Cartiva SCI instrumentation set is QBO.

Other Devices by Cartiva, Inc.

K181348Cartiva SCI Disposable Instrumentation Set PMA P150017Prosthesis, metatarsophalangeal joint cartilage replacement implant

Related Devices (Code: QBO)

K181348Cartiva SCI Disposable Instrumentation SetCartiva, Inc.

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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