FDA 510(k)

SeaSpine Beachside System

K-Number: K192132 · 2019-12-03

ApplicantSeaSpine Orthopedics Corporation

Decision Date2019-12-03

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SeaSpine Beachside 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 2019-12-03 under 510(k) number K192132. 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 Beachside System?

SeaSpine Beachside System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K192132.

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

SeaSpine Beachside System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K192132.

Who is the listed applicant for SeaSpine Beachside 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 Beachside System?

The FDA product code for SeaSpine Beachside 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.