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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2021-04-19 under 510(k) 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. The listed applicant is Conformis, Inc.. The 510(k) number is K203421.

When did Triathlon AS-1 receive FDA 510(k) clearance?

Triathlon AS-1 received FDA 510(k) clearance on 2021-04-19, under 510(k) number K203421.

Who is the listed applicant for Triathlon AS-1?

The FDA 510(k) record lists Conformis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triathlon AS-1?

The FDA product code for Triathlon AS-1 is OOG.

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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.

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