FINE Osteotomy around the knee
K-Number: K193614 · 2020-03-25
ApplicantBodycad Laboratories, Inc.
Decision Date2020-03-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FINE Osteotomy around the knee is a medical device manufactured by Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2020-03-25 under approval number K193614. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FINE Osteotomy around the knee?
FINE Osteotomy around the knee is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by Bodycad Laboratories, Inc.. The 510(k) number is K193614.
When was FINE Osteotomy around the knee approved by the FDA?
FINE Osteotomy around the knee received FDA 510(k) clearance on 2020-03-25, under approval number K193614.
What company makes FINE Osteotomy around the knee?
FINE Osteotomy around the knee is manufactured by Bodycad Laboratories, Inc..
What is the FDA product code for FINE Osteotomy around the knee?
The FDA product code for FINE Osteotomy around the knee is HRS.
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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.