Triathlon AS-1
K-Number: K203421 · 2021-04-19
ApplicantConformis, Inc.
Decision Date2021-04-19
Product CodeOOG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Triathlon AS-1 is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2021-04-19 under approval number K203421. The device is classified under product code OOG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Triathlon AS-1?
Triathlon AS-1 is a medical device that received FDA 510(k) clearance on 2021-04-19. It is manufactured by Conformis, Inc.. The 510(k) number is K203421.
When was Triathlon AS-1 approved by the FDA?
Triathlon AS-1 received FDA 510(k) clearance on 2021-04-19, under approval number K203421.
What company makes Triathlon AS-1?
Triathlon AS-1 is manufactured by Conformis, Inc..
What is the FDA product code for Triathlon AS-1?
The FDA product code for Triathlon AS-1 is OOG.
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Related Devices (Code: OOG)
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.