FDA 510(k)

2.1 x 255mm Drill, 22mm Stop

K-Number: K223199 · 2022-11-15

Decision Date2022-11-15

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

2.1 x 255mm Drill, 22mm Stop is a medical device manufactured by Biomet Microfixation. It received FDA 510(k) clearance on 2022-11-15 under approval number K223199. 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 2022-11-15. It is manufactured by Biomet Microfixation. The 510(k) number is K223199.

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 2022-11-15, under approval number K223199.

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

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

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.

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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.