FDA 510(k)

SeaSpine Skipjack System

K-Number: K193418 · 2020-03-13

ApplicantSeaSpine Orthopedics Corporation

Decision Date2020-03-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SeaSpine Skipjack System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K193418. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine Skipjack System?

SeaSpine Skipjack System is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K193418.

When did SeaSpine Skipjack System receive FDA 510(k) clearance?

SeaSpine Skipjack System received FDA 510(k) clearance on 2020-03-13, under 510(k) number K193418.

Who is the listed applicant for SeaSpine Skipjack System?

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

What is the FDA product code for SeaSpine Skipjack System?

The FDA product code for SeaSpine Skipjack System is MAX.

Other records listing SeaSpine Orthopedics 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.

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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.