FINE Osteotomy
K-Number: K211646 · 2021-07-28
ApplicantBodycad Laboratories, Inc.
Decision Date2021-07-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FINE Osteotomy is a medical device manufactured by Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2021-07-28 under approval number K211646. 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?
FINE Osteotomy is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Bodycad Laboratories, Inc.. The 510(k) number is K211646.
When was FINE Osteotomy approved by the FDA?
FINE Osteotomy received FDA 510(k) clearance on 2021-07-28, under approval number K211646.
What company makes FINE Osteotomy?
FINE Osteotomy is manufactured by Bodycad Laboratories, Inc..
What is the FDA product code for FINE Osteotomy?
The FDA product code for FINE Osteotomy 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.