TITAN 3-D Wedge System
K-Number: K162241 · 2017-04-03
ApplicantParagon 28
Decision Date2017-04-03
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TITAN 3-D Wedge System is a medical device manufactured by Paragon 28. It received FDA 510(k) clearance on 2017-04-03 under approval number K162241. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TITAN 3-D Wedge System?
TITAN 3-D Wedge System is a medical device that received FDA 510(k) clearance on 2017-04-03. It is manufactured by Paragon 28. The 510(k) number is K162241.
When was TITAN 3-D Wedge System approved by the FDA?
TITAN 3-D Wedge System received FDA 510(k) clearance on 2017-04-03, under approval number K162241.
What company makes TITAN 3-D Wedge System?
TITAN 3-D Wedge System is manufactured by Paragon 28.
What is the FDA product code for TITAN 3-D Wedge System?
The FDA product code for TITAN 3-D Wedge System is PLF.
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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.