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 a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-05-14 under approval 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. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K190670.
When was ORTHOLOC 2 Lapidus with Rotation System approved by the FDA?
ORTHOLOC 2 Lapidus with Rotation System received FDA 510(k) clearance on 2019-05-14, under approval number K190670.
What company makes ORTHOLOC 2 Lapidus with Rotation System?
ORTHOLOC 2 Lapidus with Rotation System is manufactured by Wrightmedicaltechnologyinc.
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.