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FDA 510(k)

SeaSpine Regatta Lateral System

K-Number: K181079 · 2018-07-18

ApplicantSeaSpine Orthopedics Corporation
Decision Date2018-07-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine Regatta Lateral System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2018-07-18 under approval number K181079. 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 Regatta Lateral System?

SeaSpine Regatta Lateral System is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K181079.

When was SeaSpine Regatta Lateral System approved by the FDA?

SeaSpine Regatta Lateral System received FDA 510(k) clearance on 2018-07-18, under approval number K181079.

What company makes SeaSpine Regatta Lateral System?

SeaSpine Regatta Lateral System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for SeaSpine Regatta Lateral System?

The FDA product code for SeaSpine Regatta Lateral System is MAX.

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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.

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