ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
K-Number: K163650 · 2017-04-24
ApplicantWrightmedicaltechnologyinc
Decision Date2017-04-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-04-24 under approval number K163650. 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® 3Di Ankle Fusion Plating System Line Extension?
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension is a medical device that received FDA 510(k) clearance on 2017-04-24. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K163650.
When was ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension approved by the FDA?
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension received FDA 510(k) clearance on 2017-04-24, under approval number K163650.
What company makes ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension?
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension is manufactured by Wrightmedicaltechnologyinc.
What is the FDA product code for ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension?
The FDA product code for ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension 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.