ICONN Answer II Suture Anchor
K-Number: K181680 · 2018-08-09
ApplicantIconn Orthopedics, LLC
Decision Date2018-08-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ICONN Answer II Suture Anchor is a medical device manufactured by Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2018-08-09 under approval number K181680. 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 ICONN Answer II Suture Anchor?
ICONN Answer II Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Iconn Orthopedics, LLC. The 510(k) number is K181680.
When was ICONN Answer II Suture Anchor approved by the FDA?
ICONN Answer II Suture Anchor received FDA 510(k) clearance on 2018-08-09, under approval number K181680.
What company makes ICONN Answer II Suture Anchor?
ICONN Answer II Suture Anchor is manufactured by Iconn Orthopedics, LLC.
What is the FDA product code for ICONN Answer II Suture Anchor?
The FDA product code for ICONN Answer II Suture Anchor is MBI.
Related PubMed Literature
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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.