FDA 510(k)

2.1 x 255mm Drill, 22mm Stop

K-Number: K213072 · 2022-08-23

Decision Date2022-08-23

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

2.1 x 255mm Drill, 22mm Stop is a medical device manufactured by Biomet Micofixation. It received FDA 510(k) clearance on 2022-08-23 under approval number K213072. 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 2.1 x 255mm Drill, 22mm Stop?

2.1 x 255mm Drill, 22mm Stop is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Biomet Micofixation. The 510(k) number is K213072.

When was 2.1 x 255mm Drill, 22mm Stop approved by the FDA?

2.1 x 255mm Drill, 22mm Stop received FDA 510(k) clearance on 2022-08-23, under approval number K213072.

What company makes 2.1 x 255mm Drill, 22mm Stop?

2.1 x 255mm Drill, 22mm Stop is manufactured by Biomet Micofixation.

What is the FDA product code for 2.1 x 255mm Drill, 22mm Stop?

The FDA product code for 2.1 x 255mm Drill, 22mm Stop is HBE.

Other Devices by Biomet Micofixation

K203474Biomet Microfixation RibFix Advantage System K212841Pectus Blu Support Bar System

Related Devices (Code: HBE)

K161704Phasor DrillBiotex, Inc. K153519DRealCarevature Medical, Ltd. K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation K162542OsteoMed PINNACLE DriverOsteomed K172709ELAN 4 Electro Motor System ToolsAesculap, Inc. K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.