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FDA 510(k)

AdvantageRib System

K-Number: K183317 · 2019-02-14

ApplicantSig Medical Corporation
Decision Date2019-02-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AdvantageRib System is the device name listed in this FDA 510(k) record. The listed applicant is Sig Medical Corporation. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K183317. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AdvantageRib System?

AdvantageRib System is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Sig Medical Corporation. The 510(k) number is K183317.

When did AdvantageRib System receive FDA 510(k) clearance?

AdvantageRib System received FDA 510(k) clearance on 2019-02-14, under 510(k) number K183317.

Who is the listed applicant for AdvantageRib System?

The FDA 510(k) record lists Sig Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdvantageRib System?

The FDA product code for AdvantageRib System is HRS.

Other records listing Sig Medical Corporation 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.

K182179AdvantageRib Anterior System

Related Devices (Code: HRS)

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

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

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