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 the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2022-11-15 under 510(k) 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. The listed applicant is Biomet Microfixation. The 510(k) number is K223199.

When did 2.1 x 255mm Drill, 22mm Stop receive FDA 510(k) clearance?

2.1 x 255mm Drill, 22mm Stop received FDA 510(k) clearance on 2022-11-15, under 510(k) number K223199.

Who is the listed applicant for 2.1 x 255mm Drill, 22mm Stop?

The FDA 510(k) record lists Biomet Microfixation as the applicant. This does not by itself establish the device manufacturer.

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 records listing Biomet Microfixation as applicant

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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.