ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
K-Number: K201259 · 2021-01-08
ApplicantWrightmedicaltechnologyinc
Decision Date2021-01-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2021-01-08 under approval number K201259. 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 with 3Di Technology Pilon Fracture Plating System?
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is a medical device that received FDA 510(k) clearance on 2021-01-08. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K201259.
When was ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System approved by the FDA?
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System received FDA 510(k) clearance on 2021-01-08, under approval number K201259.
What company makes ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is manufactured by Wrightmedicaltechnologyinc.
What is the FDA product code for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?
The FDA product code for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating 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.