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FDA 510(k)

ORTHOLOC™ 2 Lapidus with Rotation System

K-Number: K190670 · 2019-05-14

ApplicantWrightmedicaltechnologyinc
Decision Date2019-05-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOLOC™ 2 Lapidus with Rotation System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K190670. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOLOC™ 2 Lapidus with Rotation System?

ORTHOLOC™ 2 Lapidus with Rotation System is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K190670.

When did ORTHOLOC™ 2 Lapidus with Rotation System receive FDA 510(k) clearance?

ORTHOLOC™ 2 Lapidus with Rotation System received FDA 510(k) clearance on 2019-05-14, under 510(k) number K190670.

Who is the listed applicant for ORTHOLOC™ 2 Lapidus with Rotation System?

The FDA 510(k) record lists Wrightmedicaltechnologyinc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOLOC™ 2 Lapidus with Rotation System?

The FDA product code for ORTHOLOC™ 2 Lapidus with Rotation System is HRS.

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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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