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FDA 510(k)

Cartiva SCI Disposable Instrumentation Set

K-Number: K181348 · 2018-06-20

ApplicantCartiva, Inc.
Decision Date2018-06-20
Product CodeQBO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cartiva SCI Disposable Instrumentation Set is a medical device manufactured by Cartiva, Inc.. It received FDA 510(k) clearance on 2018-06-20 under approval number K181348. 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 Disposable Instrumentation Set?

Cartiva SCI Disposable Instrumentation Set is a medical device that received FDA 510(k) clearance on 2018-06-20. It is manufactured by Cartiva, Inc.. The 510(k) number is K181348.

When was Cartiva SCI Disposable Instrumentation Set approved by the FDA?

Cartiva SCI Disposable Instrumentation Set received FDA 510(k) clearance on 2018-06-20, under approval number K181348.

What company makes Cartiva SCI Disposable Instrumentation Set?

Cartiva SCI Disposable Instrumentation Set is manufactured by Cartiva, Inc..

What is the FDA product code for Cartiva SCI Disposable Instrumentation Set?

The FDA product code for Cartiva SCI Disposable Instrumentation Set is QBO.

Other Devices by Cartiva, Inc.

K192156Cartiva SCI instrumentation set PMA P150017Prosthesis, metatarsophalangeal joint cartilage replacement implant

Related Devices (Code: QBO)

K192156Cartiva SCI 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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