OIC FLEX-FIX System
K-Number: K233531 · 2024-02-02
ApplicantOrthopaedic Implant Company
Decision Date2024-02-02
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OIC FLEX-FIX System is a medical device manufactured by Orthopaedic Implant Company. It received FDA 510(k) clearance on 2024-02-02 under approval number K233531. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OIC FLEX-FIX System?
OIC FLEX-FIX System is a medical device that received FDA 510(k) clearance on 2024-02-02. It is manufactured by Orthopaedic Implant Company. The 510(k) number is K233531.
When was OIC FLEX-FIX System approved by the FDA?
OIC FLEX-FIX System received FDA 510(k) clearance on 2024-02-02, under approval number K233531.
What company makes OIC FLEX-FIX System?
OIC FLEX-FIX System is manufactured by Orthopaedic Implant Company.
What is the FDA product code for OIC FLEX-FIX System?
The FDA product code for OIC FLEX-FIX System is HTN.
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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.