RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
K-Number: K190774 · 2019-07-25
ApplicantMedos International SARL
Decision Date2019-07-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2019-07-25 under approval number K190774. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant?
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Medos International SARL. The 510(k) number is K190774.
When was RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant approved by the FDA?
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant received FDA 510(k) clearance on 2019-07-25, under approval number K190774.
What company makes RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant?
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant is manufactured by Medos International SARL.
What is the FDA product code for RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant?
The FDA product code for RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant is MBI.
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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.