FDA 510(k)

Cartiva SCI instrumentation set

K-Number: K192156 · 2019-09-04

Decision Date2019-09-04

Product CodeQBO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cartiva SCI instrumentation set is the device name listed in this FDA 510(k) record. The listed applicant is Cartiva, Inc.. It received FDA 510(k) clearance on 2019-09-04 under 510(k) 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. The listed applicant is Cartiva, Inc.. The 510(k) number is K192156.

When did Cartiva SCI instrumentation set receive FDA 510(k) clearance?

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

Who is the listed applicant for Cartiva SCI instrumentation set?

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

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

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

Other records listing Cartiva, Inc. as applicant

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.

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

Related Devices (Code: QBO)

K181348Cartiva SCI Disposable Instrumentation SetCartiva, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.