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FDA 510(k)

External Remote Controller ERC 4P

K-Number: K202348 · 2020-12-22

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2020-12-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

External Remote Controller ERC 4P is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-12-22 under approval number K202348. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the External Remote Controller ERC 4P?

External Remote Controller ERC 4P is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K202348.

When was External Remote Controller ERC 4P approved by the FDA?

External Remote Controller ERC 4P received FDA 510(k) clearance on 2020-12-22, under approval number K202348.

What company makes External Remote Controller ERC 4P?

External Remote Controller ERC 4P is manufactured by Nuvasive Specialized Orthopedics, Inc..

What is the FDA product code for External Remote Controller ERC 4P?

The FDA product code for External Remote Controller ERC 4P is HSB.

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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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