TenoTac Soft Tissue Fixation System
K-Number: K203385 · 2021-02-11
ApplicantParagon 28, Inc.
Decision Date2021-02-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TenoTac Soft Tissue Fixation System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2021-02-11 under approval number K203385. 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 TenoTac Soft Tissue Fixation System?
TenoTac Soft Tissue Fixation System is a medical device that received FDA 510(k) clearance on 2021-02-11. It is manufactured by Paragon 28, Inc.. The 510(k) number is K203385.
When was TenoTac Soft Tissue Fixation System approved by the FDA?
TenoTac Soft Tissue Fixation System received FDA 510(k) clearance on 2021-02-11, under approval number K203385.
What company makes TenoTac Soft Tissue Fixation System?
TenoTac Soft Tissue Fixation System is manufactured by Paragon 28, Inc..
What is the FDA product code for TenoTac Soft Tissue Fixation System?
The FDA product code for TenoTac Soft Tissue Fixation System 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.