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 a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2019-12-03 under approval 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. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K192132.
When was SeaSpine Beachside System approved by the FDA?
SeaSpine Beachside System received FDA 510(k) clearance on 2019-12-03, under approval number K192132.
What company makes SeaSpine Beachside System?
SeaSpine Beachside System is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for SeaSpine Beachside System?
The FDA product code for SeaSpine Beachside System is MAX.
Other Devices by SeaSpine Orthopedics Corporation
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K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161535SeaSpine® NewPort Spinal System
K160902Mariner Pedicle Screw System
K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical
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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.