Twist Drills
K-Number: K213208 · 2021-12-23
ApplicantBiomet Microfixation
Decision Date2021-12-23
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Twist Drills is a medical device manufactured by Biomet Microfixation. It received FDA 510(k) clearance on 2021-12-23 under approval number K213208. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Twist Drills?
Twist Drills is a medical device that received FDA 510(k) clearance on 2021-12-23. It is manufactured by Biomet Microfixation. The 510(k) number is K213208.
When was Twist Drills approved by the FDA?
Twist Drills received FDA 510(k) clearance on 2021-12-23, under approval number K213208.
What company makes Twist Drills?
Twist Drills is manufactured by Biomet Microfixation.
What is the FDA product code for Twist Drills?
The FDA product code for Twist Drills is HBE.
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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.