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FDA 510(k)

Explorer TO System

K-Number: K212540 · 2021-09-10

ApplicantSeaSpine Orthopedics Corporation
Decision Date2021-09-10
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Explorer TO System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-09-10 under approval number K212540. 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 Explorer TO System?

Explorer TO System is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K212540.

When was Explorer TO System approved by the FDA?

Explorer TO System received FDA 510(k) clearance on 2021-09-10, under approval number K212540.

What company makes Explorer TO System?

Explorer TO System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Explorer TO System?

The FDA product code for Explorer TO 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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