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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 the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) 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. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K202348.

When did External Remote Controller ERC 4P receive FDA 510(k) clearance?

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

Who is the listed applicant for External Remote Controller ERC 4P?

The FDA 510(k) record lists Nuvasive Specialized Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Nuvasive Specialized Orthopedics, Inc. as applicant

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Related Devices (Code: HSB)

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

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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