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FDA 510(k)

EARP Interbody System

K-Number: K212477 · 2022-04-28

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2022-04-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EARP Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K212477. 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 EARP Interbody System?

EARP Interbody System is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K212477.

When did EARP Interbody System receive FDA 510(k) clearance?

EARP Interbody System received FDA 510(k) clearance on 2022-04-28, under 510(k) number K212477.

Who is the listed applicant for EARP Interbody System?

The FDA 510(k) record lists Nvision Biomedical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EARP Interbody System?

The FDA product code for EARP Interbody 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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