OsteoPlan System
K-Number: K212570 · 2022-02-11
ApplicantOsteomed, LLC
Decision Date2022-02-11
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OsteoPlan System is a medical device manufactured by Osteomed, LLC. It received FDA 510(k) clearance on 2022-02-11 under approval number K212570. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OsteoPlan System?
OsteoPlan System is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Osteomed, LLC. The 510(k) number is K212570.
When was OsteoPlan System approved by the FDA?
OsteoPlan System received FDA 510(k) clearance on 2022-02-11, under approval number K212570.
What company makes OsteoPlan System?
OsteoPlan System is manufactured by Osteomed, LLC.
What is the FDA product code for OsteoPlan System?
The FDA product code for OsteoPlan System is DZJ.
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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.