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FDA 510(k), K213208, Twist Drills
FDA 510(k), K213208, Twist Drills
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510(K) Number: K213208
Device Name: Twist Drills
Manufacturer: Biomet Microfixation
Device Classification Name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation Number: 882.4310
Classification Product Code: HBE
Date Received: 09/29/2021
Decision Date: 12/23/2021
Regulation Medical Specialty: Neurology
Device Name: Twist Drills
Manufacturer: Biomet Microfixation
Device Classification Name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation Number: 882.4310
Classification Product Code: HBE
Date Received: 09/29/2021
Decision Date: 12/23/2021
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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